Hansaton
Sound SHD S13 stream myChoice (sterling silver)
4manufacturers in China registered for this device type
249catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (3), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GN Resound China, Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Sonova Hearing (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 3 |
| Jiangsu Betterlife Medical Co., Ltd. | Jiangsu | Jiangsu | Manufacturer | 4 |
| Starkey (Suzhou) Hearing Technology Co., Ltd. | Guoxiang, Wuzhong District, Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Hansaton Akustik GmbH, Germany |
|---|---|
| FDA product code | KLW |
| Device type | Masker, Tinnitus |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3400 |
| Premarket notification | Exempt |
| Record published | 2018-02-28 |
| Record revised | 2020-10-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 063-6068-01 | In distribution | |
| 050-6024-U6 | In distribution | |
| 063-6088-01 | In distribution | |
| 050-5742-U569 | In distribution | |
| 050-5924-U3 | In distribution | |
| 050-5932-U8 | In distribution | |
| 050-6000-U3 | In distribution | |
| 050-5931-U8 | In distribution | |
| 050-5711-U669 | In distribution | |
| 050-6024-U8 | In distribution | |
| 050-6086-U4 | In distribution | |
| 063-6070-01 | In distribution | |
| 063-6073-01 | In distribution | |
| 050-5990-U3 | In distribution | |
| 050-6002-U3 | In distribution | |
| 050-6001-U6 | In distribution | |
| 050-6026-U4 | In distribution | |
| 050-5749-U9 | In distribution | |
| 050-6008-U4 | In distribution | |
| 050-6086-U9 | In distribution | |
| 050-5743-U969 | In distribution | |
| 050-5995-U4 | In distribution | |
| 050-5741-U869 | In distribution | |
| 050-5992-U4 | In distribution | |
| 050-6008-U5 | In distribution | |
| 063-6075-01 | In distribution | |
| 050-6091-U5 | In distribution | |
| 050-6001-U769 | In distribution | |
| 050-5934-U4 | In distribution | |
| 050-5899-U7 | In distribution | |
| 050-6005-U8 | In distribution | |
| 050-5712-U969 | In distribution | |
| 050-5746-U6 | In distribution | |
| 050-6091-U4 | In distribution | |
| 050-5900-U4 | In distribution | |
| 050-6003-U4 | In distribution | |
| 050-5749-U3 | In distribution | |
| 050-5931-U9 | In distribution | |
| 063-6074-01 | In distribution | |
| 050-6002-V7 | In distribution | |
| 050-5927-U6 | In distribution | |
| 050-6023-U5 | In distribution | |
| 050-5924-U9 | In distribution | |
| 050-6092-U8 | In distribution | |
| 050-5747-U369 | In distribution | |
| 063-6076-01 | In distribution | |
| 050-6090-U3 | In distribution | |
| 050-5898-U5 | In distribution | |
| 050-5993-U9 | In distribution | |
| 050-5926-U8 | In distribution | |
| 050-6001-U9 | In distribution | |
| 050-6003-U7 | In distribution | |
| 050-6087-U4 | In distribution | |
| 063-6080-01 | In distribution | |
| 050-6003-U8 | In distribution | |
| 050-5997-U7 | In distribution | |
| 063-6089-01 | In distribution | |
| 050-6022-U5 | In distribution | |
| 050-5932-U5 | In distribution | |
| 063-6079-01 | In distribution | |
| 050-5996-U6 | In distribution | |
| 050-6024-U4 | In distribution | |
| 050-6091-U8 | In distribution | |
| 050-5990-U5 | In distribution | |
| 050-5896-U3 | In distribution | |
| 050-6007-U3 | In distribution | |
| 050-6025-U9 | In distribution | |
| 050-5712-U669 | In distribution | |
| 050-5996-U5 | In distribution | |
| 050-5997-U6 | In distribution | |
| 050-6088-U9 | In distribution | |
| 050-6005-U5 | In distribution | |
| 050-5926-U5 | In distribution | |
| 063-6072-01 | In distribution | |
| 050-5924-U6 | In distribution | |
| 050-6005-U4 | In distribution | |
| 050-5992-U6 | In distribution | |
| 050-5934-P6 | In distribution | |
| 050-5899-U4 | In distribution | |
| 050-5899-U3 | In distribution | |
| 050-5993-U8 | In distribution | |
| 050-6025-U7 | In distribution | |
| 050-6000-U369 | In distribution | |
| 050-6005-U7 | In distribution | |
| 050-6007-U4 | In distribution | |
| 050-5713-U669 | In distribution | |
| 050-5990-U4 | In distribution | |
| 050-5998-U8 | In distribution | |
| 050-6089-U4 | In distribution | |
| 050-5932-U7 | In distribution | |
| 050-5926-U6 | In distribution | |
| 050-6003-V7 | In distribution | |
| 050-5931-U6 | In distribution | |
| 050-5925-U6 | In distribution | |
| 050-5991-U7 | In distribution | |
| 050-5993-U3 | In distribution | |
| 050-5927-U4 | In distribution | |
| 050-5897-U5 | In distribution | |
| 050-5930-U3 | In distribution | |
| 050-5991-U3 | In distribution | |
| 050-5990-U8 | In distribution | |
| 050-6002-U8 | In distribution | |
| 050-6088-U3 | In distribution | |
| 050-6008-U8 | In distribution | |
| 050-5896-U7 | In distribution | |
| 050-5748-U7 | In distribution | |
| 050-6086-U6 | In distribution | |
| 050-5713-U469 | In distribution | |
| 063-6078-01 | In distribution | |
| 050-5935-U4 | In distribution | |
| 050-5930-U8 | In distribution | |
| 050-5712-U469 | In distribution | |
| 050-5746-U9 | In distribution | |
| 050-5713-U369 | In distribution | |
| 050-5746-U8 | In distribution | |
| 050-5897-U7 | In distribution | |
| 050-6005-U3 | In distribution | |
| 050-5995-U5 | In distribution | |
| 050-5933-U4 | In distribution | |
| 050-6094-U4 | In distribution | |
| 050-6007-V7 | In distribution | |
| 050-5931-U4 | In distribution | |
| 050-5996-U4 | In distribution | |
| 050-5749-U5 | In distribution | |
| 050-6092-U9 | In distribution | |
| 050-6001-U5 | In distribution | |
| 050-6023-U9 | In distribution | |
| 050-5990-U9 | In distribution | |
| 050-6008-V7 | In distribution | |
| 050-5746-U369 | In distribution | |
| 050-5997-U4 | In distribution | |
| 050-5747-U9 | In distribution | |
| 050-5741-U969 | In distribution | |
| 050-5997-U5 | In distribution | |
| 050-6092-U6 | In distribution | |
| 050-5896-U8 | In distribution | |
| 050-6090-U5 | In distribution | |
| 050-5926-U9 | In distribution | |
| 050-5995-U6 | In distribution | |
| 050-6003-U9 | In distribution | |
| 050-6000-U8 | In distribution | |
| 050-6025-V7 | In distribution | |
| 050-5742-U669 | In distribution | |
| 050-5992-U8 | In distribution | |
| 050-5746-U5 | In distribution | |
| 050-6008-U3 | In distribution | |
| 050-5748-U8 | In distribution | |
| 050-5998-U3 | In distribution | |
| 050-5896-U4 | In distribution | |
| 050-5742-U369 | In distribution | |
| 050-5747-U5 | In distribution | |
| 050-5998-U9 | In distribution | |
| 050-5927-U5 | In distribution | |
| 050-6001-U969 | In distribution | |
| 050-5990-U7 | In distribution | |
| 050-5932-U3 | In distribution | |
| 050-6000-U7 | In distribution | |
| 050-5998-U7 | In distribution | |
| 050-6003-U3 | In distribution | |
| 050-5747-U769 | In distribution | |
| 050-5748-U3 | In distribution | |
| 050-5742-U469 | In distribution | |
| 050-5927-U9 | In distribution | |
| 050-6085-U9 | In distribution | |
| 050-6004-U4 | In distribution | |
| 050-6087-U5 | In distribution | |
| 050-6024-U5 | In distribution | |
| 050-5993-U5 | In distribution | |
| 050-5993-U4 | In distribution | |
| 063-6081-01 | In distribution | |
| 050-5749-U6 | In distribution | |
| 050-6085-U4 | In distribution | |
| 063-6082-01 | In distribution | |
| 050-5746-U969 | In distribution | |
| 050-6006-U5 | In distribution | |
| 050-5930-U7 | In distribution | |
| 050-6023-U8 | In distribution | |
| 050-5746-U7 | In distribution | |
| 050-6000-U9 | In distribution | |
| 050-6023-U3 | In distribution | |
| 050-5747-U869 | In distribution | |
| 063-6084-01 | In distribution | |
| 050-5743-U569 | In distribution | |
| 050-5927-U3 | In distribution | |
| 050-6025-U4 | In distribution | |
| 050-6088-U5 | In distribution | |
| 050-5747-U8 | In distribution | |
| 050-5932-U6 | In distribution | |
| 050-5747-U7 | In distribution | |
| 050-5990-U6 | In distribution | |
| 050-5748-U5 | In distribution | |
| 050-6000-U6 | In distribution | |
| 050-6087-U6 | In distribution | |
| 063-6067-01 | In distribution | |
| 050-6000-U5 | In distribution | |
| 050-5899-U5 | In distribution | |
| 050-5897-U3 | In distribution | |
| 050-6001-U7 | In distribution | |
| 050-5998-U4 | In distribution | |
| 050-6088-U6 | In distribution | |
| 050-5930-U6 | In distribution | |
| 050-5933-U5 | In distribution | |
| 050-5899-V7 | In distribution | |
| 050-5991-U9 | In distribution | |
| 063-6071-01 | In distribution | |
| 050-6003-U5 | In distribution | |
| 050-6022-U9 | In distribution | |
| 050-6024-V7 | In distribution | |
| 050-6000-U669 | In distribution | |
| 050-6023-U4 | In distribution | |
| 050-6002-U6 | In distribution | |
| 050-5747-U6 | In distribution | |
| 050-5933-U3 | In distribution | |
| 050-6002-U9 | In distribution | |
| 050-6002-U4 | In distribution | |
| 050-5897-U6 | In distribution | |
| 050-5898-U6 | In distribution | |
| 050-5993-U7 | In distribution | |
| 050-5997-U9 | In distribution | |
| 050-5992-U5 | In distribution | |
| 050-5993-U6 | In distribution | |
| 050-5926-U7 | In distribution | |
| 050-5992-U7 | In distribution | |
| 050-5713-U969 | In distribution | |
| 050-5992-U3 | In distribution | |
| 063-6077-01 | In distribution | |
| 050-5997-U3 | In distribution | |
| 050-5898-U3 | In distribution | |
| 050-5991-U8 | In distribution | |
| 050-5996-U7 | In distribution | |
| 050-5746-U469 | In distribution | |
| 050-6093-U4 | In distribution | |
| 050-5933-U9 | In distribution | |
| 063-6069-01 | In distribution | |
| 050-5747-U4 | In distribution | |
| 050-5995-U7 | In distribution | |
| 050-5998-U5 | In distribution | |
| 050-5997-U8 | In distribution | |
| 050-5925-U4 | In distribution | |
| 050-5925-U9 | In distribution | |
| 050-6008-U7 | In distribution | |
| 063-6090-01 | In distribution | |
| 050-6001-U4 | In distribution | |
| 050-5925-U7 | In distribution | |
| 050-6009-U4 | In distribution | |
| 050-6003-U6 | In distribution | |
| 063-6083-01 | In distribution | |
| 050-6001-U669 | In distribution | |
| 050-6022-U7 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oticon | Sbo Hearing A/S | 570 |
| Starkey | Starkey Laboratories, Inc. | 449 |
| Phonak | Sonova AG | 448 |
| Oticon | Oticon A/S | 353 |
| Nuear | Starkey Laboratories, Inc. | 336 |
| Audibel | Starkey Laboratories, Inc. | 318 |
| Unitron | Unitron Hearing Division | 292 |
| Audigy | Starkey Laboratories, Inc. | 284 |
| Microtech | Starkey Laboratories, Inc. | 284 |
| audifon | Audifon – Gmbh & Co.kg | 277 |
| Philips | Sbo Hearing A/S | 270 |
| Agxo | Sbo Hearing A/S | 260 |
Showing 12 of 86. All products under Masker, Tinnitus
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130937 | 2014-01-03 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.