MODIFICATION TO GE LOGIQ A3

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 Modification To Ge Logiq A3.

Pre-market Notification Details

Device IDK072075
510k NumberK072075
Device Name:MODIFICATION TO GE LOGIQ A3
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant GENERAL ELECTRIC CO. 9900 INNOVATION DRIVE MAIL CODE: RP-2138 Wauwatosa,  WI  53226
ContactAllen Schuh
CorrespondentAllen Schuh
GENERAL ELECTRIC CO. 9900 INNOVATION DRIVE MAIL CODE: RP-2138 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 Received2007-07-30
Decision Date2007-08-29
Summary:summary

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