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 US6 Tymp with IPSI, CONTRA, Reflex decay ETF Content: 1. Sentiero Desktop (Tymp Diagnostic) AN100434-DG 2. USB data cable AN100418 3. Probe EP-TY long AN100188-US 4. DD45 Contra HB7 headphone (calibrated) AN100725 5. FW Reflex & Tymp class1 AN100561 6. Software label printer AN100414 7. 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 8. Accessory box for Tymp probe AN100587 9. Accessory box AB08 AN100734-P 10. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally 11. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 12. Test cavity tymp AN100549 FDA UDI
Model / Reference: 100497-US6 FDA UDI
Description: Sentiero Desktop Diagnostic Set US6 Tymp with IPSI, CONTRA, Reflex decay ETF Content: 1. Sentiero Desktop (Tymp Diagnostic) AN100434-DG 2. USB data cable AN100418 3. Probe EP-TY long AN100188-US 4. DD45 Contra HB7 headphone (calibrated) AN100725 5. FW Reflex & Tymp class1 AN100561 6. Software label printer AN100414 7. 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 8. Accessory box for Tymp probe AN100587 9. Accessory box AB08 AN100734-P 10. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally 11. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 12. Test cavity tymp AN100549 FDA UDI

Identifiers

Primary DI / UDI-DI: 04260223141522 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

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

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Cleared under the same submission

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 f78256dd-c4a8-44d2-9e41-0bd679767306 34 fields · synced Jun 8, 2026