Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60— 510(k) K202687

Substantially Equivalent

Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.

FDA 510(k) clearance K202687 for Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60, Substantially Equivalent on 2021-02-18. Applicant: Shenzhen Lepu Intelligent Medical Equipment Co., Ltd..

Clearance details

Applicant: Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.
Product code: 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

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.