Sentiero AuDX
Sentiero AuDX Set Content: 1. Sentiero Screening device AN100098-AU 2. Carrying case AN100928 3. Inlay AN100677 4. Probe EP-DP Path long AN100028-US 5. Accessory box Combo AB-03 AN100261-BL…
Sentiero AuDX Set Content: 1. Sentiero Screening device AN100098-AU 2. Carrying case AN100928 3. Inlay AN100677 4. Probe EP-DP Path long AN100028-US 5. Accessory box Combo AB-03 AN100261-BL 6. DPOAE Quick Software AN100110-Quick 7. FMDPOAE Software AN100536 8. Software label printer AN100414 9. USB data cable AN100089 10. USB stick Bio-Logic AN100724-BL 11. Power supply Sentiero AN101013+AN100993-USA 12. Manual Bio-Logic AN100904-EN-BL
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Dong Guan Danchen Electrical Products Ltd. | Dong Guan | Guangdong | Contract manufacturer | 2 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Path, Germany |
|---|---|
| FDA product code | GWJ |
| Device type | Stimulator, Auditory, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1900 |
| Establishment | Manufacturer |
| 510(k) | K133012 |
| Record published | 2018-06-01 |
| Record revised | 2020-06-24 (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 |
|---|---|---|
| 8-04-16510 | In distribution | |
| 8-04-16500 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GN Otometrics A/S | Natus Medical Denmark ApS | 117 |
| Natus Medical | Natus Medical Incorporated | 25 |
| QScreen Set | Path | 24 |
| AccuScreen | Natus Medical Denmark ApS | 20 |
| Natus | Natus Medical Incorporated | 18 |
| Sentiero Advanced | Path | 14 |
| Algo Pro | Natus Medical Denmark ApS | 9 |
| Algo Pro | Xltek | 9 |
| Stimulator, Auditory, Evoked Response | Medtronic Xomed, Inc. | 7 |
| Algo 3i | Natus Medical Denmark ApS | 5 |
| Teoae probe tips | Otodynamics, Ltd. | 5 |
| Algo 5 | Natus Medical Denmark ApS | 5 |
Showing 12 of 305. All products under Stimulator, Auditory, Evoked Response
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220139 | 2022-08-03 |
| K211147 | 2021-10-14 |
| K131141 | 2013-06-27 |
| K100661 | 2010-07-01 |
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 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason |
|---|---|---|---|
| 2025-11-06 | Class II | Component change control | Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses |
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.