Clearance Summary
CARDIOMEM CM 3000-12 received FDA 510(k) clearance under submission number K051686, sponsored by Getemed Medizin- Und Informationstechnik AG. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2005-07-14.
- Submission: K051686
- Applicant / Sponsor: Getemed Medizin- Und Informationstechnik AG
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2005-07-14
Classification & Regulation
This clearance is catalogued under FDA product code MWJ and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.