Clearance Summary
Braun Thermoscan PRO 6000 Ear Thermometer received FDA 510(k) clearance under submission number K152748, sponsored by Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc). 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 2016-03-01.
- Submission: K152748
- Applicant / Sponsor: Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc)
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2016-03-01
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.