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Sentiero Desktop AuditData Tymp only

PATH medical GmbH · Model 100497-AD1 · UDI-DI 04260223142840

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Sentiero Desktop Auditdata Diagnsotic Set AD1, Tymp only. Content: 1. Sentiero Desktop (Tymp Diagnostic) AN100434-DW 2. Ear probe EP-TY AN100188-US 3. USB data cable AN100418 4. Software label printer AN100414 5. FW Screening Tymp Class 2 AN100560 6. Accessory box for Tymp Auditdata AN100587-AD 7. Accessory box AB08 AN100734-P 8. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or 101251-USA/-UK/-EU/-AUS optionally 9. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 10. Test cavity tymp AN100549

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.