Clearance Summary
BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 received FDA 510(k) clearance under submission number K941921, sponsored by Medtronic Bio-Medicus, 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 1994-07-20.
- Submission: K941921
- Applicant / Sponsor: Medtronic Bio-Medicus, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4380
- Decision date: 1994-07-20
Classification & Regulation
This clearance is catalogued under FDA product code DWA and 21 CFR 870.4380, within the Cardiovascular review panel as a Class II device.