Sentiero Screening
Sentiero Screening OAE + Audiometry Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable AN100089 4. Sentiero Screening device with touchscreen AN100098-S 5. Headphone…
Sentiero Screening OAE + Audiometry Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable AN100089 4. Sentiero Screening device with touchscreen AN100098-S 5. Headphone HB7 / DD-45 AN100306-US 6. Probe EP-DP Path long AN100028-US 7. Pure Tone Audiometer Class 4A AN100653 8. DPOAE Quick Software AN100110-Quick 9. FMDPOAE Software AN100536 10. Software label printer AN100414 11. Accessory box Sentiero Screening AN100676 12. Power supply Sentiero US AN101013 + AN100993-USA
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 5) |
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 |
|---|---|---|
| 100250-US0 | In distribution | |
| 100250-US1 | 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.