Clearance Summary
FILAC FAS TEMP ELECTRONIC THERMOMETER received FDA 510(k) clearance under submission number K003313, sponsored by The Kendall Company. 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 2001-01-11.
- Submission: K003313
- Applicant / Sponsor: The Kendall Company
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2001-01-11
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.