Clearance Summary
CARDIAN III CR6A received FDA 510(k) clearance under submission number K864704, sponsored by Cardiac Recorders, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1987-03-20.
- Submission: K864704
- Applicant / Sponsor: Cardiac Recorders, Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 1987-03-20
Classification & Regulation
This clearance is catalogued under FDA product code DPS and 21 CFR 870.2340, within the Cardiovascular review panel as a Class II device.