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Sentiero Desktop AuDX PRO FLEX

PATH medical GmbH · Model 8-04-16540 · UDI-DI 04260223143540

ETY GWJ EWO Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Sentiero Desktop AuDX PRO FLEX Set: Content: 1. Sentiero Desktop AN100434-AUPF 2. Cardboard Box AN100728 3. Cardboard Sleeve Bio-Logic AN100723-Biologic 4. Probe EP-TY long AN100188-US 5. Accessory box Combo AB-03 AN100261-BL 6. Accessory box AB08 AN100734-P 7. FW Screening Tymp class 2 AN100560 8. Software label printer AN100414 9. USB data cable AN100418 10. USB stick Bio-Logic AN100724-BL 11. Test cavity tymp AN100549 12. Power supply Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 13. Power supply adapter Sentiero Desktop US AN100525-USA or AN101251-USA optionally 14. Manual Bio-Logic AN100904-EN-BL

Recalls

Date	Firm	Reason
2005-06-27	Natus Medical Inc	Internal investigation revealed that Preamp cable assemblies in the device had not been properly tested, which could lead to potential shock to users.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.