Identity
- Trade Name
- Sentiero AuDX PRO FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Sentiero AuDX PRO Set Content: 1. Sentiero Diagnostic device AN100098-AUP 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 Software AN100110 7. FMDPOAE Software AN100536 8. DPHiRes Software AN100537 9. Software label printer AN100414 10. PC Patient Management Software AN100116 11. USB data cable AN100089 12. USB stick Bio-Logic AN100724-BL 13. Power supply Sentiero AN101013+AN100993-USA 14. Manual Bio-Logic AN100904-EN-BL FDA UDI
- Model / Reference
- 8-04-16520 FDA UDI
- Description
- Sentiero AuDX PRO Set Content: 1. Sentiero Diagnostic device AN100098-AUP 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 Software AN100110 7. FMDPOAE Software AN100536 8. DPHiRes Software AN100537 9. Software label printer AN100414 10. PC Patient Management Software AN100116 11. USB data cable AN100089 12. USB stick Bio-Logic AN100724-BL 13. Power supply Sentiero AN101013+AN100993-USA 14. Manual Bio-Logic AN100904-EN-BL FDA UDI
Identifiers
- Catalog Number
- 100250-BL-US3 FDA UDI
- Primary DI / UDI-DI
- 04260223143472 FDA UDI
- 510(k) Number
- K133012 FDA UDI
- FDA Product Code
- GWJ FDA UDIEWO FDA UDI
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1900 FDA UDI874.1050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Evoked-potential audiometer
Sentiero AuDX PRO by PATH medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Evoked-potential audiometer.
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- Tip Sample Box (Neonate) — Otodynamics · Class II
- Otoport LCD service kit — Otodynamics · Class II
- TEOAE probe tips — Otodynamics · Class II
- ABR Case service kit - Top — Otodynamics · Class II
- Otoport ABR Binaural Upgrade Kit (TE) — Otodynamics · Class II
- ABR Test Cavity — Otodynamics · Class II
Cleared under the same submission
K133012 also covers:
- AuDX Device with touchscreen — PATH medical GmbH
- AuDX PRO FLEX Device with touchscreen — PATH medical GmbH
- Bone Conductor B71W — PATH medical GmbH
- Bone Conductor B81 — PATH medical GmbH
- Bone Conductor B81 — PATH medical GmbH
- Ear Coupler Cable — PATH medical GmbH
- Ear Coupler Cable — PATH medical GmbH
- Ear Coupler Set — PATH medical GmbH
- Ear Tip IT-02 Pack/100 pcs. — PATH medical GmbH
- Ear Tip IT-03 Pack/100 pcs. — PATH medical GmbH
- Headphone DD-45 contra — PATH medical GmbH
- Headphone DD-65 — PATH medical GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- PATH medical GmbH
Sources (1)
- FDA UDI 609fc6c7-09e4-484a-a66c-957292044d83 35 fields · synced Jun 6, 2026