Clearance Summary
CMI MAGNETOCARDIOGRAPH received FDA 510(k) clearance under submission number K033488, sponsored by Cmi Cardiomag Imaging, 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 2004-07-07.
- Submission: K033488
- Applicant / Sponsor: Cmi Cardiomag Imaging, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2004-07-07
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.