Clearance Summary
YUWELL Infrared Thermometer received FDA 510(k) clearance under submission number K201864, 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 2020-12-07.
- Submission: K201864
- 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: 2020-12-07
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.