Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701)— 510(k) K210171

Substantially Equivalent

Sichuan Youkede Medical Equipment Co.,Ltd

FDA 510(k) clearance K210171 for Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701), Substantially Equivalent on 2022-03-18. Applicant: Sichuan Youkede Medical Equipment Co.,Ltd.

Clearance details

Applicant: Sichuan Youkede Medical Equipment Co.,Ltd
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2021-01-22
Decision date: 2022-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mianyang, 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.