Clearance Summary
VitalFlow Console received FDA 510(k) clearance under submission number K230364, sponsored by Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.). The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2023-08-25.
- Submission: K230364
- Applicant / Sponsor: Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4100
- Decision date: 2023-08-25
Classification & Regulation
This clearance is catalogued under FDA product code QNR and 21 CFR 870.4100, within the Cardiovascular review panel as a Class II device.