UlrichINJECT CT Motion

Injector, Contrast Medium, Automatic

Ulrich GmbH & Co. KG

The following data is part of a premarket notification filed by Ulrich Gmbh & Co. Kg with the FDA for Ulrichinject Ct Motion.

Pre-market Notification Details

Device IDK192872
510k NumberK192872
Device Name:UlrichINJECT CT Motion
ClassificationInjector, Contrast Medium, Automatic
Applicant ulrich GmbH & Co. KG Buchbrunnenweg 12 Ulm,  DE 89081
ContactSven Erdmann
CorrespondentRita King
MethodSense, Inc. 1 Copley Parkway, Suite 410 Morrisville,  NC  27560
Product CodeIZQ  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2019-10-08
Decision Date2020-07-02

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