510(k) K102033

COMBITRANS MONITORING SETS AND ACCESSORIES by B.Braun Melsungen AG — Product Code DRS

K102033 is an FDA 510(k) premarket notification submitted by B.Braun Melsungen AG for the device "COMBITRANS MONITORING SETS AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on April 7, 2011. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. B.Braun Melsungen AG has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2011
Date Received
July 19, 2010
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Blood-Pressure, Extravascular
Device Class
Class II
Regulation Number
870.2850
Review Panel
CV
Submission Type