MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1— 510(k) K033820

Substantially Equivalent

Microlife Intellectual Property GmbH

FDA 510(k) clearance K033820 for MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1, Substantially Equivalent on 2004-02-23. Applicant: Microlife Intellectual Property GmbH.

Clearance details

Applicant: Microlife Intellectual Property GmbH
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2003-12-09
Decision date: 2004-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, 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.