510(k) K172831

Perfusor® Space Syringe Infusion Pump System by B.Braun Medical, Inc. — Product Code FRN

K172831 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "Perfusor® Space Syringe Infusion Pump System". The FDA issued a decision of Substantially Equivalent on Jun 12, 2018. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. B.Braun Medical, Inc. has 149 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 12, 2018
Date Received
Sep 18, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type
510(k)