MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE

Computer, Diagnostic, Programmable

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES

The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Muse Cardiology Information System With Vmware.

Pre-market Notification Details

Device IDK083639
510k NumberK083639
Device Name:MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE
ClassificationComputer, Diagnostic, Programmable
Applicant GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 9900 INNOVATION DR. Wauwatosa,  WI  53226
ContactLarry Lepley
CorrespondentLarry Lepley
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 9900 INNOVATION DR. Wauwatosa,  WI  53226
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-09
Decision Date2009-02-17
Summary:summary

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