Identity
- Trade Name
- Sentiero Desktop AuDX PRO FLEX FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Sentiero Desktop AuDX PRO FLEX Set: Content: 1. Sentiero Desktop AN100434-AUPF 2. Cardboard Box AN100728 3. Cardboard Sleeve Bio-Logic AN100723-Biologic 4. Probe EP-TY long AN100188-US 5. Accessory box Combo AB-03 AN100261-BL 6. Accessory box AB08 AN100734-P 7. FW Screening Tymp class 2 AN100560 8. Software label printer AN100414 9. USB data cable AN100418 10. USB stick Bio-Logic AN100724-BL 11. Test cavity tymp AN100549 12. Power supply Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 13. Power supply adapter Sentiero Desktop US AN100525-USA or AN101251-USA optionally 14. Manual Bio-Logic AN100904-EN-BL FDA UDI
- Model / Reference
- 8-04-16540 FDA UDI
- Description
- Sentiero Desktop AuDX PRO FLEX Set: Content: 1. Sentiero Desktop AN100434-AUPF 2. Cardboard Box AN100728 3. Cardboard Sleeve Bio-Logic AN100723-Biologic 4. Probe EP-TY long AN100188-US 5. Accessory box Combo AB-03 AN100261-BL 6. Accessory box AB08 AN100734-P 7. FW Screening Tymp class 2 AN100560 8. Software label printer AN100414 9. USB data cable AN100418 10. USB stick Bio-Logic AN100724-BL 11. Test cavity tymp AN100549 12. Power supply Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 13. Power supply adapter Sentiero Desktop US AN100525-USA or AN101251-USA optionally 14. Manual Bio-Logic AN100904-EN-BL FDA UDI
Identifiers
- Catalog Number
- 100497-BL-US1 FDA UDI
- Primary DI / UDI-DI
- 04260223143540 FDA UDI
- 510(k) Number
- K133012 FDA UDI
- FDA Product Code
- ETY FDA UDIGWJ FDA UDIEWO FDA UDI
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1090 FDA UDI882.1900 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 Desktop AuDX PRO FLEX 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 24f73d05-0923-47d0-a743-0ee36ffcddaa 35 fields · synced May 30, 2026