GE LOGIQ 9 MODEL 2375600

System, Imaging, Pulsed Doppler, Ultrasonic

GE MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Ge Logiq 9 Model 2375600.

Pre-market Notification Details

Device IDK030934
510k NumberK030934
Device Name:GE LOGIQ 9 MODEL 2375600
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee,  WI  53201
ContactAllen Schuh
CorrespondentAllen Schuh
GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee,  WI  53201
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-25
Decision Date2003-04-17
Summary:summary

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