CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER— 510(k) K070028

Substantially Equivalent

Actherm, Inc.

FDA 510(k) clearance K070028 for CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER, Substantially Equivalent on 2007-02-08. Applicant: Actherm, Inc..

Clearance details

Applicant: Actherm, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2007-01-03
Decision date: 2007-02-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Jubei, 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.