Identity
- Trade Name
- Sentiero Diagnostic FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Sentiero Diagnostic OAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable AN100089 4. Sentiero Diagnostic device with touchscreen AN100098 5. Probe EP-DP Path long AN100028-US 6. DPOAE Software AN100110 7. FMDPOAE Software AN100536 8. DPHiRES Software AN100537 9. Software label printer AN100414 10. 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 11. Accessory Box Sentiero Combo AN100261 12. Power supply Sentiero AN101013+AN100993-USA FDA UDI
- Model / Reference
- 100250-US2 FDA UDI
- Description
- Sentiero Diagnostic OAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable AN100089 4. Sentiero Diagnostic device with touchscreen AN100098 5. Probe EP-DP Path long AN100028-US 6. DPOAE Software AN100110 7. FMDPOAE Software AN100536 8. DPHiRES Software AN100537 9. Software label printer AN100414 10. 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 11. Accessory Box Sentiero Combo AN100261 12. Power supply Sentiero AN101013+AN100993-USA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223141430 FDA UDI
- 510(k) Number
- K133012 FDA UDI
- FDA Product Code
- EWO FDA UDIGWJ FDA UDI
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 FDA UDI882.1900 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 Diagnostic by PATH medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Evoked-potential audiometer.
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- 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 753005d4-576b-4a6f-a749-451a7d3b6879 34 fields · synced May 30, 2026