ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED ACCU2010— 510(k) K093795

Substantially Equivalent

Actherm, Inc.

FDA 510(k) clearance K093795 for ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED ACCU2010, Substantially Equivalent on 2010-03-12. Applicant: Actherm, Inc..

Clearance details

Applicant: Actherm, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2009-12-10
Decision date: 2010-03-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Hsinchu, TW

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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.