Clearance Summary
SYSTEM V.HEART RATE/RESPIR. RATE MONIT. received FDA 510(k) clearance under submission number K820114, 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 1982-02-12.
- Submission: K820114
- Applicant / Sponsor: Narco Air-Shields
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 1982-02-12
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.