Clearance Summary
MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122 received FDA 510(k) clearance under submission number K040228, sponsored by Medi-Stim A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-04-29.
- Submission: K040228
- Applicant / Sponsor: Medi-Stim A/S
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2100
- Decision date: 2004-04-29
Classification & Regulation
This clearance is catalogued under FDA product code DPW and 21 CFR 870.2100, within the Cardiovascular review panel as a Class II device.