CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM

Computer, Diagnostic, Programmable

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH

The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies Gmbh with the FDA for Case Cardiac Testing System, Cs Cardiac Testing System.

Pre-market Notification Details

Device IDK103678
510k NumberK103678
Device Name:CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM
ClassificationComputer, Diagnostic, Programmable
Applicant GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH MUNZINGER STRASSE 5 Freiburg,baden Wurttemberg,  DE 79111
ContactAlbrecht Malkmus
CorrespondentAlbrecht Malkmus
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH MUNZINGER STRASSE 5 Freiburg,baden Wurttemberg,  DE 79111
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-16
Decision Date2011-02-16
Summary:summary

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