Clearance Summary
Braun BFH175 Infrared Forehead Thermometer received FDA 510(k) clearance under submission number K181015, sponsored by Kaz USA, Inc., A Helen of Troy Company. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2018-07-18.
- Submission: K181015
- Applicant / Sponsor: Kaz USA, Inc., A Helen of Troy Company
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2018-07-18
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.