510(k) K210014— Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)

Substantially Equivalent

Guandong Genial Technology Co., Limited

Clearance details

Applicant: Guandong Genial Technology Co., Limited
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2021-01-04
Decision date: 2021-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhaoqing, CN

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.