Clearance Summary
YUWELL infrared ear thermometer: YHT101, YHT200 received FDA 510(k) clearance under submission number K203583, sponsored by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2021-05-20.
- Submission: K203583
- Applicant / Sponsor: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2021-05-20
Classification & Regulation
This clearance is catalogued under FDA product code FLL and 21 CFR 880.2910, within the General Hospital review panel as a Class II device.