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Sentiero Desktop Diagnostic

FDA UDI

Class II (US FDA UDI)

by PATH medical GmbH

Identity

Trade Name
Sentiero Desktop Diagnostic FDA UDI
Generic Name
Evoked-potential audiometer FDA UDI
Device Name
Sentiero Desktop Diagnostic Set US7 Diagnostic Tymp with Diagnostic OAE 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. FW Reflex & Tymp class1 AN100561 6. Software label printer AN100414 7. DPOAE Software AN100110 8. TEOAE Software AN100109 9. DPHiRES Software AN100537 10. FMDPOAE Software AN100536 11. 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 12. Accessory box for Tymp probe AN100587 13. Accessory box AB08 AN100734-P 14. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 15. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally 16. Test cavity tymp AN100549 FDA UDI
Model / Reference
100497-US7 FDA UDI
Description
Sentiero Desktop Diagnostic Set US7 Diagnostic Tymp with Diagnostic OAE 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. FW Reflex & Tymp class1 AN100561 6. Software label printer AN100414 7. DPOAE Software AN100110 8. TEOAE Software AN100109 9. DPHiRES Software AN100537 10. FMDPOAE Software AN100536 11. 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 12. Accessory box for Tymp probe AN100587 13. Accessory box AB08 AN100734-P 14. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 15. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally 16. Test cavity tymp AN100549 FDA UDI

Identifiers

Primary DI / UDI-DI
04260223141539 FDA UDI
510(k) Number
K133012 FDA UDI
FDA Product Code
EWO FDA UDI
GWJ FDA UDI
ETY FDA UDI
GMDN Term
Evoked-potential audiometer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.1050 FDA UDI
882.1900 FDA UDI
874.1090 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.

Cleared under the same submission

K133012 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PATH medical GmbH

Sources (1)

  • FDA UDI a4ae3646-6492-42b6-812a-145b14011aae 34 fields · synced Jun 8, 2026