Clearance Summary
COMBITRANS MONITORING SETS AND ACCESSORIES received FDA 510(k) clearance under submission number K102033, sponsored by B.Braun Melsungen AG. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-04-07.
- Submission: K102033
- Applicant / Sponsor: B.Braun Melsungen AG
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2850
- Decision date: 2011-04-07
Classification & Regulation
This clearance is catalogued under FDA product code DRS and 21 CFR 870.2850, within the Cardiovascular review panel as a Class II device.