Speech & Bone Kit Sentiero Desktop
Content: 1. Bone conductor calibrated (Sentiero Advanced / Sentiero desktop, Senti desktop flex) AN100888 2. Gooseneck microphone AN100779 3. FW Live AN100825 4. UT-08 Spondee Words for…
Content: 1. Bone conductor calibrated (Sentiero Advanced / Sentiero desktop, Senti desktop flex) AN100888 2. Gooseneck microphone AN100779 3. FW Live AN100825 4. UT-08 Spondee Words for Children (English) AN100819 5. UT-10 Spondee Words for Adults (English) AN100821 6. UT-11 Northwestern University Auditory Test No. 6 (English) AN100822 7. UT-12 Central Institute for the Deaf Auditory Test W22 (English) AN100823 8. UT-13 PBK-50 (English) AN100824
Who Else Makes It
All of them in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Fastsound Acoustic Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 6 |
| Zoomax Technology Co., Limited | Hangzhou | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Path, Germany |
|---|---|
| FDA product code | EWO |
| Device type | Audiometer |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1050 |
| Establishment | Manufacturer |
| 510(k) | K133012 |
| Record published | 2016-08-31 |
| Record revised | 2021-02-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100780-D | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RadioEar A/S | Interacoustics A/S | 131 |
| GN Otometrics A/S | Natus Medical Denmark ApS | 88 |
| Audiometer | Etymotic Research, Inc. | 73 |
| Siemens | WS Audiology USA, Inc. | 57 |
| Bio-logic | Natus Medical Incorporated | 33 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 29 |
| Real-EAR | WS Audiology USA, Inc. | 26 |
| Sanibel Supply A/S | Interacoustics A/S | 18 |
| Natus | Natus Medical Incorporated | 14 |
| Grason-Stadler | Diagnostic Group LLC | 12 |
| Interacoustics | Interacoustics A/S | 12 |
| Oscilla | Inmedico A/S | 12 |
Showing 12 of 348. All products under Audiometer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213345 | 2022-06-22 |
| K133012 | 2014-06-09 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Path | 510(k) number | 2023-09-26 | Class II | Process change control | Affected lots of product may experience technical distortions to a greater extent than expected. | 15 units |
| Path | 510(k) number | 2023-09-26 | Class II | Process change control | Affected lots of product may experience technical distortions to a greater extent than expected. | 28 units |
| Path | 510(k) number | 2023-09-26 | Class II | Process change control | Affected lots of product may experience technical distortions to a greater extent than expected. | 23 units |
| Path | 510(k) number | 2023-09-26 | Class II | Process change control | Affected lots of product may experience technical distortions to a greater extent than expected. | 1 unit |
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.