Clearance Summary
INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22 received FDA 510(k) clearance under submission number K063291, sponsored by Choice Smart Health Care 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 2006-11-21.
- Submission: K063291
- Applicant / Sponsor: Choice Smart Health Care Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2006-11-21
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.