GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000

System, Imaging, Pulsed Doppler, Ultrasonic

GENERAL ELECTRIC CO.

The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Logiq 9, Models 2188900, 2375600, 2404587 And 5150000.

Pre-market Notification Details

Device IDK061129
510k NumberK061129
Device Name:GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant GENERAL ELECTRIC CO. 99000 INNOVATION DRIVE Wauwatosa,  WI  53226
ContactPatricia Taige
CorrespondentPatricia Taige
GENERAL ELECTRIC CO. 99000 INNOVATION DRIVE Wauwatosa,  WI  53226
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-24
Decision Date2006-06-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682117968 K061129 000
00840682117289 K061129 000
00840682117272 K061129 000
00840682117227 K061129 000
00840682107655 K061129 000

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