A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER— 510(k) K993116

Substantially Equivalent

A&D Engineering, Inc.

FDA 510(k) clearance K993116 for A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER, Substantially Equivalent on 2000-04-12. Applicant: A&D Engineering, Inc..

Clearance details

Applicant: A&D Engineering, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1999-09-20
Decision date: 2000-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milpitas, CA, US

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Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.