Infrared Forehead Thermometer, FT-100A— 510(k) K160802

Substantially Equivalent

Hangzhou Universal Electronic Co., Ltd.

FDA 510(k) clearance K160802 for Infrared Forehead Thermometer, FT-100A, Substantially Equivalent on 2016-08-24. Applicant: Hangzhou Universal Electronic Co., Ltd..

Clearance details

Applicant: Hangzhou Universal Electronic Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2016-03-23
Decision date: 2016-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou City, CN

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.