K203583

Substantially Equivalent

YUWELL infrared ear thermometer: YHT101, YHT200

Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Product code: FLL
Advisory panel: General Hospital
Date received: 2020-12-08
Decision date: 2021-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiangsu, 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.