K250878

Substantially Equivalent

YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)

Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Product code: FLL
Advisory panel: General Hospital
Date received: 2025-03-24
Decision date: 2025-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danyang, 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.