K202687

Substantially Equivalent

Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60

Applicant: Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.
Product code: FLL
Advisory panel: General Hospital
Date received: 2020-09-15
Decision date: 2021-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, 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.