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 Screening TY / Diagnostic Set US13 Content: 1. Carton for Sentiero Desktop AN100728 2. Sentiero Desktop (Tymp Diagnostic) AN100434-DG 3. USB data cable AN100418 4. Probe EP-TY long AN100188-US 5. Headphone DD-45 AN100306 6. FW Screening Tymp class 2 AN100560 7. FW Pure Tone Audiometer Class 3 AN100114 8. Bone conductor B81 AN100888 or B71W AN100344 optionally 9. Patient response button AN100171 10. DPOAE Software AN100110 11. TEOAE Software AN100109 12. DPHiRES Software AN100537 13. FMDPOAE Software AN100536 14. PC based Patient Management, Mira Software AN100116 15. Software label printer AN100414 16. Accessory box for Tymp probe AN100587 17. Accessory box AB08 AN100734-P 18. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 19. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally 20. Test cavity tymp AN100549 FDA UDI
Model / Reference: 100497-US13 FDA UDI
Description: Sentiero Desktop Screening TY / Diagnostic Set US13 Content: 1. Carton for Sentiero Desktop AN100728 2. Sentiero Desktop (Tymp Diagnostic) AN100434-DG 3. USB data cable AN100418 4. Probe EP-TY long AN100188-US 5. Headphone DD-45 AN100306 6. FW Screening Tymp class 2 AN100560 7. FW Pure Tone Audiometer Class 3 AN100114 8. Bone conductor B81 AN100888 or B71W AN100344 optionally 9. Patient response button AN100171 10. DPOAE Software AN100110 11. TEOAE Software AN100109 12. DPHiRES Software AN100537 13. FMDPOAE Software AN100536 14. PC based Patient Management, Mira Software AN100116 15. Software label printer AN100414 16. Accessory box for Tymp probe AN100587 17. Accessory box AB08 AN100734-P 18. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 19. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally 20. Test cavity tymp AN100549 FDA UDI

Identifiers

Primary DI / UDI-DI: 04260223141584 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

Similar devices

Also classified as Evoked-potential audiometer.

ECochG Adapters — Vivosonic Inc · Class II
TE Tip Sample Box — Otodynamics · Class II
Tip Sample Box (Neonate) — Otodynamics · Class II
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

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 838717b3-aa07-45fb-8abe-f9169b2a174b 34 fields · synced May 30, 2026