Agxo
H330V2 TI, Minirite 312 WL PB CBE Demo Agxo
4manufacturers in China registered for this device type
56catalogue 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 | Oticon A/S, Denmark |
|---|---|
| FDA product code | KLW |
| Device type | Masker, Tinnitus |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3400 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-09-20 |
| Record revised | 2020-10-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 150872 | In distribution | |
| 193310 | In distribution | |
| 193321 | In distribution | |
| 149432 | In distribution | |
| 149608 | In distribution | |
| 150229 | In distribution | |
| 151076 | In distribution | |
| 150225 | In distribution | |
| 149523 | In distribution | |
| 151078 | In distribution | |
| 193468 | In distribution | |
| 151080 | In distribution | |
| 150456 | In distribution | |
| 193309 | In distribution | |
| 149435 | In distribution | |
| 149431 | In distribution | |
| 150245 | In distribution | |
| 193467 | In distribution | |
| 149609 | In distribution | |
| 153883 | In distribution | |
| 150436 | In distribution | |
| 193540 | In distribution | |
| 150871 | In distribution | |
| 150247 | In distribution | |
| 193318 | In distribution | |
| 193462 | In distribution | |
| 193539 | In distribution | |
| 150248 | In distribution | |
| 193319 | In distribution | |
| 151075 | In distribution | |
| 166311 | In distribution | |
| 151074 | In distribution | |
| 193463 | In distribution | |
| 149433 | In distribution | |
| 193313 | In distribution | |
| 150434 | In distribution | |
| 150437 | In distribution | |
| 150251 | In distribution | |
| 193470 | In distribution | |
| 193537 | In distribution | |
| 193317 | In distribution | |
| 150873 | In distribution | |
| 193312 | In distribution | |
| 150439 | In distribution | |
| 193314 | In distribution | |
| 193308 | In distribution | |
| 149437 | In distribution | |
| 150435 | In distribution | |
| 193464 | In distribution | |
| 193311 | In distribution | |
| 149610 | In distribution | |
| 151079 | In distribution | |
| 149526 | In distribution | |
| 149525 | In distribution | |
| 193304 | In distribution | |
| 193469 | 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 |
|---|---|
| K133308 | 2014-03-18 |
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.