Sentiero Advanced
PATH medical GmbH · Model 100340-SC-ALL-LT · UDI-DI 04260223145247
Description
Sentiero Advanced ABR, OAE, Tympanometry and Audio Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable AN100089 4. Path electrodes: 30 pcs. / bag. Each bag contains 10 sets of 3 pcs. AN 100468 5. Sentiero Advanced device with touchscreen AN100360 6. ABR electrode cable AN100307 7. Headphone DD-45 AN100306 8. Probe EP-LT AN101021 9. Accessory box EP-LT AN101043 10. ABR Quick SW AN100337-Quick 11. TEOAE Quick SW AN100109-Quick 12. DPOAE Quick SW AN100110-Quick 13. FMDPOAE SW AN100536 14. Tymp Class 2 SW AN100560 15. Audio Class 4 Advanced SW AN100653 16. Mira PC Patient Management SW AN100116 17. Label Printer SW AN100414 18. Power Supply Sentiero Advanced US AN101016+AN100993-USA 19. Tympanometry add-on TY-MA AN100947 20. Accessory box AB08 AN100734-P 21. Tympanometry cavity AN100549 22. Probe tip small PT-S AN100014-W (3 pcs.) 23. Probe tip medium PT-A AN100013 (5 pcs.)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-06 | PATH | Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance |
| 2019-05-28 | GN Otometrics | There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock. |
| 2010-06-04 | Natus Medical Inc | There is insufficient evidence to support any claims for safety and efficacy on the SonaMed Clarity devices. |
| 2008-10-21 | Intelligent Hearing Systems Corp. | This was a marketing correction mandated by the United States Food and Drug Administration (USFDA). USFDA notified Intelligent Hearing Systems that 501(k) premarket notification ap |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docs