510(k) K173531

Lockbox for Perfusor Space PCA Infusion Pump by B.Braun Medical, Inc. — Product Code MRZ

K173531 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "Lockbox for Perfusor Space PCA Infusion Pump". The FDA issued a decision of Substantially Equivalent on August 2, 2018. The device falls under product code MRZ (Accessories, Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. B.Braun Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2018
Date Received
November 15, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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