Clearance Summary
Infrared Forehead Thermometer, FT-100A received FDA 510(k) clearance under submission number K160802, sponsored by Hangzhou Universal Electronic 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 2016-08-24.
- Submission: K160802
- Applicant / Sponsor: Hangzhou Universal Electronic Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2016-08-24
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.