Clearance Summary
CARDIODAY received FDA 510(k) clearance under submission number K130516, sponsored by Getemed Medizin- Und Informationstechnik AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2013-08-23.
- Submission: K130516
- Applicant / Sponsor: Getemed Medizin- Und Informationstechnik AG
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1425
- Decision date: 2013-08-23
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.