Clearance Summary
VICKERS MEDICAL MODEL 271 HEART RATE MONITOR received FDA 510(k) clearance under submission number K854597, sponsored by Vickers , 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 1986-05-09.
- Submission: K854597
- Applicant / Sponsor: Vickers , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 1986-05-09
Classification & Regulation
This clearance is catalogued under FDA product code DRT and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.