MICROLIFE DUAL MODE THERMOMETER,MODEL IFR1MJ1— 510(k) K113141

Substantially Equivalent

Microlife Intellectual Property GmbH

FDA 510(k) clearance K113141 for MICROLIFE DUAL MODE THERMOMETER,MODEL IFR1MJ1, Substantially Equivalent on 2012-01-27. Applicant: Microlife Intellectual Property GmbH.

Clearance details

Applicant: Microlife Intellectual Property GmbH
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2011-10-24
Decision date: 2012-01-27
Decision: Substantially Equivalent
Clearance type: Special
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.