Clearance Summary
NARCO AIR-SHEILDS SYS. 100 MONITOR SYS received FDA 510(k) clearance under submission number K802800, 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 1980-11-24.
- Submission: K802800
- Applicant / Sponsor: Narco Air-Shields
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1435
- Decision date: 1980-11-24
Classification & Regulation
This clearance is catalogued under FDA product code DXG and 21 CFR 870.1435, within the Cardiovascular review panel as a Class II device.