GE ECHOPAC

System, Image Processing, Radiological

GENERAL ELECTRIC CO.

The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Echopac.

Pre-market Notification Details

Device IDK072952
510k NumberK072952
Device Name:GE ECHOPAC
ClassificationSystem, Image Processing, Radiological
Applicant GENERAL ELECTRIC CO. 9900 Innovation Drive Wauwatosa,  WI  53226
ContactAllen Schuh
CorrespondentAllen Schuh
GENERAL ELECTRIC CO. 9900 Innovation Drive Wauwatosa,  WI  53226
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-18
Decision Date2007-11-16
Summary:summary

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