Clearance Summary
HEART-AID MODEL 80 received FDA 510(k) clearance under submission number K843358, sponsored by Cardiac Resucitator Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1984-11-19.
- Submission: K843358
- Applicant / Sponsor: Cardiac Resucitator Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5550
- Decision date: 1984-11-19
Classification & Regulation
This clearance is catalogued under FDA product code DRO and 21 CFR 870.5550, within the Cardiovascular review panel as a Class II device.