510(k) K092313

PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM by B.Braun Medical, Inc. — Product Code MEA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2009
Date Received
July 30, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Pca
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type