Clearance Summary
INFARED EAR THERMOMETER, MODEL TH8 SERIES received FDA 510(k) clearance under submission number K011059, sponsored by Radiant Innovation, 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 2001-09-17.
- Submission: K011059
- Applicant / Sponsor: Radiant Innovation, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2001-09-17
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.