Clearance Summary
TEMP-A-SURE received FDA 510(k) clearance under submission number K010866, sponsored by Homecare Technologies , 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 2001-06-06.
- Submission: K010866
- Applicant / Sponsor: Homecare Technologies , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2001-06-06
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.