LOGIQ S7 Expert

System, Imaging, Pulsed Doppler, Ultrasonic

GE Healthcare

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Logiq S7 Expert.

Pre-market Notification Details

Device IDK160182
510k NumberK160182
Device Name:LOGIQ S7 Expert
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant GE Healthcare 9900 Innovation Dr. Wauwatosa,  WI  53226
ContactBryan Behn
CorrespondentBryan Behn
GE Healthcare 9900 Innovation Dr. 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 Received2016-01-27
Decision Date2016-02-26
Summary:summary

NIH GUDID Devices

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