Clearance Summary
INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5 received FDA 510(k) clearance under submission number K042656, sponsored by Draeger Medical Systems, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-10-06.
- Submission: K042656
- Applicant / Sponsor: Draeger Medical Systems, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2004-10-06
Classification & Regulation
This clearance is catalogued under FDA product code MHX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.