Clearance Summary
VICARDIO 12B received FDA 510(k) clearance under submission number K082380, sponsored by Energy-Lab Technologies 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 2008-12-03.
- Submission: K082380
- Applicant / Sponsor: Energy-Lab Technologies GmbH
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2008-12-03
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.