Clearance Summary
BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS received FDA 510(k) clearance under submission number K103800, sponsored by Kaz USA, Inc (A Subsidiaryof Kaz Inc). 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 2011-01-26.
- Submission: K103800
- Applicant / Sponsor: Kaz USA, Inc (A Subsidiaryof Kaz Inc)
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2011-01-26
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.