INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM

Pump, Infusion

B. BRAUN MEDICAL, INC.

The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Infusomat Space Volumetric Infusion Pump System.

Pre-market Notification Details

Device IDK062700
510k NumberK062700
Device Name:INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
ClassificationPump, Infusion
Applicant B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown,  PA  18109 -9341
ContactScott Pease
CorrespondentStefan Preiss
TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton,  MN  55112 -1891
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2006-09-11
Decision Date2006-10-26
Summary:summary

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