Clearance Summary
CARDIOCALL CARDIAC EVENT RECORDER received FDA 510(k) clearance under submission number K972649, sponsored by Reynolds Medical , 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 1997-12-04.
- Submission: K972649
- Applicant / Sponsor: Reynolds Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2920
- Decision date: 1997-12-04
Classification & Regulation
This clearance is catalogued under FDA product code DXH and 21 CFR 870.2920, within the Cardiovascular review panel as a Class II device.