Identity
- Trade Name
- Sentiero Desktop AuditData Tymp only FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Sentiero Desktop Auditdata Diagnsotic Set AD1, Tymp only. Content: 1. Sentiero Desktop (Tymp Diagnostic) AN100434-DW 2. Ear probe EP-TY AN100188-US 3. USB data cable AN100418 4. Software label printer AN100414 5. FW Screening Tymp Class 2 AN100560 6. Accessory box for Tymp Auditdata AN100587-AD 7. Accessory box AB08 AN100734-P 8. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or 101251-USA/-UK/-EU/-AUS optionally 9. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 10. Test cavity tymp AN100549 FDA UDI
- Model / Reference
- 100497-AD1 FDA UDI
- Description
- Sentiero Desktop Auditdata Diagnsotic Set AD1, Tymp only. Content: 1. Sentiero Desktop (Tymp Diagnostic) AN100434-DW 2. Ear probe EP-TY AN100188-US 3. USB data cable AN100418 4. Software label printer AN100414 5. FW Screening Tymp Class 2 AN100560 6. Accessory box for Tymp Auditdata AN100587-AD 7. Accessory box AB08 AN100734-P 8. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or 101251-USA/-UK/-EU/-AUS optionally 9. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 10. Test cavity tymp AN100549 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223142840 FDA UDI
- 510(k) Number
- K133012 FDA UDI
- FDA Product Code
- ETY FDA UDIEWO FDA UDIGWJ FDA UDI
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1090 FDA UDI874.1050 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 Desktop AuditData Tymp only 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
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- 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 aae62937-d8eb-4f83-8b43-51505959433b 34 fields · synced May 31, 2026