Clearance Summary
MEDILOGAR4, MEDILOGAR12 received FDA 510(k) clearance under submission number K070818, sponsored by Tom Medical Entwicklungs GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-04-06.
- Submission: K070818
- Applicant / Sponsor: Tom Medical Entwicklungs GmbH
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2007-04-06
Classification & Regulation
This clearance is catalogued under FDA product code DSH and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.