DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136, AND ACT 3030— 510(k) K031905

Substantially Equivalent

Actherm, Inc.

FDA 510(k) clearance K031905 for DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136, AND ACT 3030, Substantially Equivalent on 2003-07-07. Applicant: Actherm, Inc..

Clearance details

Applicant: Actherm, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2003-06-20
Decision date: 2003-07-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Hsinchu, TW

Download summary PDF View on FDA.gov ↗

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.