YUWELL infrared ear thermometer: YHT101, YHT200— 510(k) K203583

Substantially Equivalent

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

FDA 510(k) clearance K203583 for YUWELL infrared ear thermometer: YHT101, YHT200, Substantially Equivalent on 2021-05-20. Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd..

Clearance details

Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Product code: 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

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.