Clearance Summary
MEDISTIM VERIQC SYSTEM received FDA 510(k) clearance under submission number K102595, sponsored by Medi-Stim Asa. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-12-27.
- Submission: K102595
- Applicant / Sponsor: Medi-Stim Asa
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2100
- Decision date: 2010-12-27
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.