ACTHERM DIGITAL CLINICAL THERMOMETER PROBE COVERS, MODEL(S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020— 510(k) K083419

Substantially Equivalent

Actherm, Inc.

FDA 510(k) clearance K083419 for ACTHERM DIGITAL CLINICAL THERMOMETER PROBE COVERS, MODEL(S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020, Substantially Equivalent on 2009-07-16. Applicant: Actherm, Inc..

Clearance details

Applicant: Actherm, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2008-11-19
Decision date: 2009-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
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.