Sentiero Desktop Screening

FDA UDI

Class II (US FDA UDI)

by PATH medical GmbH

Identity

Trade Name: Sentiero Desktop Screening FDA UDI
Generic Name: Evoked-potential audiometer FDA UDI
Device Name: Sentiero Desktop Screening Set US5 Screening OAE with Screening Tymp (IPSI&CONTRA) & Screening Audio Content: 1. Sentiero Desktop (Tymp Screening) AN100434-SB 2. USB data cable AN100418 3. Probe EP-TY long AN100188-US 4. DD45 HB7 headphone (calibrated) AN100306-US 5. FW Screening Tymp class 2 AN100560 6. DPOAE Quick Software AN100110-Quick 7. FMDPOAE Software AN100536 8. Pure Tone Audiometer Class 4 Advanced AN100653 9. Software label printer AN100414 10. Accessory box for Tymp probe AN100587 11. Accessory box AB08 AN100734-P 12. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 13. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally 14. Test cavity tymp AN100549 FDA UDI
Model / Reference: 100497-US5 FDA UDI
Description: Sentiero Desktop Screening Set US5 Screening OAE with Screening Tymp (IPSI&CONTRA) & Screening Audio Content: 1. Sentiero Desktop (Tymp Screening) AN100434-SB 2. USB data cable AN100418 3. Probe EP-TY long AN100188-US 4. DD45 HB7 headphone (calibrated) AN100306-US 5. FW Screening Tymp class 2 AN100560 6. DPOAE Quick Software AN100110-Quick 7. FMDPOAE Software AN100536 8. Pure Tone Audiometer Class 4 Advanced AN100653 9. Software label printer AN100414 10. Accessory box for Tymp probe AN100587 11. Accessory box AB08 AN100734-P 12. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 13. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally 14. Test cavity tymp AN100549 FDA UDI

Identifiers

Primary DI / UDI-DI: 04260223141515 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 Screening 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

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 2b88df94-0919-49f7-93a4-4b560f772b2e 34 fields · synced May 30, 2026