SpaceStation MRI

Accessories, Pump, Infusion

B. Braun Melsugen AG

The following data is part of a premarket notification filed by B. Braun Melsugen Ag with the FDA for Spacestation Mri.

Pre-market Notification Details

Device IDK191910
510k NumberK191910
Device Name:SpaceStation MRI
ClassificationAccessories, Pump, Infusion
Applicant B. Braun Melsugen AG Carl-Braun-Strasse 1 Melsungen,  DE 34212
ContactUllrich Trottier
CorrespondentAndre Kindsvater
Emergo Global Consulting , LLC 2500 Bee Cave Road Austin,  TX  78746
Product CodeMRZ  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-17
Decision Date2020-03-12

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