Clearance Summary
MULTIVARIATE DIGITAL CARDIOGRAPH received FDA 510(k) clearance under submission number K840875, sponsored by Clinical Microsystems Intl.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1984-07-06.
- Submission: K840875
- Applicant / Sponsor: Clinical Microsystems Intl.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1425
- Decision date: 1984-07-06
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.