Clearance Summary
BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD) received FDA 510(k) clearance under submission number K022596, sponsored by Clover Hi-Tech, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2003-01-31.
- Submission: K022596
- Applicant / Sponsor: Clover Hi-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1425
- Decision date: 2003-01-31
Classification & Regulation
This clearance is catalogued under FDA product code DQK and 21 CFR 870.1425, within the Cardiovascular review panel as a Class II device.