Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1— 510(k) K161728

Substantially Equivalent

Microfile Intellectual Property GmbH

FDA 510(k) clearance K161728 for Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1, Substantially Equivalent on 2016-12-05. Applicant: Microfile Intellectual Property GmbH.

Clearance details

Applicant: Microfile Intellectual Property GmbH
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2016-06-22
Decision date: 2016-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Widnau, CH

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.