Identity
- Trade Name
- Sentiero AuDX FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- 8-04-16510 FDA UDI
- Description
- 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 FDA UDI
Identifiers
- Catalog Number
- 100250-BL-US2 FDA UDI
- Primary DI / UDI-DI
- 04260223143441 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 by PATH medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Evoked-potential audiometer.
- ECochG Adapters — Vivosonic Inc · Class II
- TE Tip Sample Box — Otodynamics · Class II
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PATH medical GmbH
Sources (1)
- FDA UDI 73bca970-907f-4a7b-b994-8899112b12cb 35 fields · synced May 30, 2026