Clearance Summary
CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH received FDA 510(k) clearance under submission number K013367, 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 2001-12-13.
- Submission: K013367
- Applicant / Sponsor: Reynolds Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2001-12-13
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.