Clearance Summary
INFRARED BODY THERMOMETER (Model: YK-001) received FDA 510(k) clearance under submission number K210118, sponsored by Longnan Renzhong Medical Equipment 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 2021-09-15.
- Submission: K210118
- Applicant / Sponsor: Longnan Renzhong Medical Equipment Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2021-09-15
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.