Clearance Summary
AIR-SHIELDS HEART RATE MONITOR received FDA 510(k) clearance under submission number K792117, sponsored by Narco Air-Shields. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1979-11-13.
- Submission: K792117
- Applicant / Sponsor: Narco Air-Shields
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 1979-11-13
Classification & Regulation
This clearance is catalogued under FDA product code DRT and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.