Clearance Summary
RESP. AIR TEMP. CONTROL & HAZARD MON. received FDA 510(k) clearance under submission number K761295, sponsored by Harris-Lake, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1976-12-30.
- Submission: K761295
- Applicant / Sponsor: Harris-Lake, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5270
- Decision date: 1976-12-30
Classification & Regulation
This clearance is catalogued under FDA product code BZE and 21 CFR 868.5270, within the Anesthesiology review panel as a Class II device.