Infrared Non-contact Thermometer, Model ACT8100— 510(k) K162509

Substantially Equivalent

Easywell Biomedicals, Inc.

FDA 510(k) clearance K162509 for Infrared Non-contact Thermometer, Model ACT8100, Substantially Equivalent on 2017-03-10. Applicant: Easywell Biomedicals, Inc..

Clearance details

Applicant: Easywell Biomedicals, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2016-09-08
Decision date: 2017-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
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.