Clearance Summary
TRACKER-2 CHANNEL ECG TAPE RECORDER received FDA 510(k) clearance under submission number K821516, 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 1982-05-28.
- Submission: K821516
- Applicant / Sponsor: Reynolds Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 1982-05-28
Classification & Regulation
This clearance is catalogued under FDA product code DSH and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.