Identity
- Trade Name
- Sentiero Desktop Diagnostic FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Sentiero Desktop Diagnostic Set US9 Diagnostic OAE with Diagnostic Tymp, Audio, DPOAE Threshold estimation software, Simultaneous DPOAE measurements on both ears (two probes incl.) Content: 1. Sentiero Desktop (Tymp Diagnostic) AN100434-DG 2. USB data cable AN100418 3. Probe EP-TY long AN100188-US 4. Probe EP-DP VIP blue AN100539-US 5. DD45 HB7 headphone (calibrated) AN100306-US 6. Bone conductor B81 (calibrated) AN100888 or B71W optionally. 7. Gooseneck microphone AN100779 8. FW Reflex & Tymp class1 AN100561 9. Software label printer AN100414 10. Label printer cable Senti / Sentiero desktop AN100417 11. DPOAE Software AN100110 12. TEOAE Software AN100109 13. DPHiRES Software AN100537 14. FMDPOAE Software AN100536 15. DPOAE Threshold Estimation Software AN100111 16. PC based Patient Management, Mira Software: Patient data & result transfer from instrument to PC, reporting options, export functions, printing via PC, data archive for Windows 10, Windows 7 etc. AN100116 17. FW Live AN100825 18. UT-08 Spondee Words for Children (English) AN100819 19. UT-10 Spondee Words for Adults (English) AN100821 20. UT-11 Northwestern University Auditory Test No. 6 (English) AN100822 21. UT-12 Central Institute for the Deaf W22 AN100823 22. UT-13 PBK-50 (English) AN100824 23. Accessory box for Tymp probe AN100587 24. Accessory box AB08 AN100734-P 25. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 26. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally 27. Test cavity tymp AN100549 28. PTA Class 3 Software AN100114 FDA UDI
- Model / Reference
- 100497-US9 FDA UDI
- Description
- Sentiero Desktop Diagnostic Set US9 Diagnostic OAE with Diagnostic Tymp, Audio, DPOAE Threshold estimation software, Simultaneous DPOAE measurements on both ears (two probes incl.) Content: 1. Sentiero Desktop (Tymp Diagnostic) AN100434-DG 2. USB data cable AN100418 3. Probe EP-TY long AN100188-US 4. Probe EP-DP VIP blue AN100539-US 5. DD45 HB7 headphone (calibrated) AN100306-US 6. Bone conductor B81 (calibrated) AN100888 or B71W optionally. 7. Gooseneck microphone AN100779 8. FW Reflex & Tymp class1 AN100561 9. Software label printer AN100414 10. Label printer cable Senti / Sentiero desktop AN100417 11. DPOAE Software AN100110 12. TEOAE Software AN100109 13. DPHiRES Software AN100537 14. FMDPOAE Software AN100536 15. DPOAE Threshold Estimation Software AN100111 16. PC based Patient Management, Mira Software: Patient data & result transfer from instrument to PC, reporting options, export functions, printing via PC, data archive for Windows 10, Windows 7 etc. AN100116 17. FW Live AN100825 18. UT-08 Spondee Words for Children (English) AN100819 19. UT-10 Spondee Words for Adults (English) AN100821 20. UT-11 Northwestern University Auditory Test No. 6 (English) AN100822 21. UT-12 Central Institute for the Deaf W22 AN100823 22. UT-13 PBK-50 (English) AN100824 23. Accessory box for Tymp probe AN100587 24. Accessory box AB08 AN100734-P 25. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 26. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally 27. Test cavity tymp AN100549 28. PTA Class 3 Software AN100114 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223141553 FDA UDI
- 510(k) Number
- K133012 FDA UDI
- FDA Product Code
- EWO FDA UDIGWJ FDA UDIETY FDA UDI
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 FDA UDI882.1900 FDA UDI874.1090 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 Diagnostic 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 fa3ac108-dcd8-4afb-ba21-b45930df95f4 34 fields · synced Jun 8, 2026