Clearance Summary
AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) received FDA 510(k) clearance under submission number K010462, sponsored by Avita Corporation. 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 2001-04-11.
- Submission: K010462
- Applicant / Sponsor: Avita Corporation
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2001-04-11
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.