GE LOGIQ P5 MODEL H44662LD

System, Imaging, Pulsed Doppler, Ultrasonic

GE HEALTHCARE

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Ge Logiq P5 Model H44662ld.

Pre-market Notification Details

Device IDK101878
510k NumberK101878
Device Name:GE LOGIQ P5 MODEL H44662LD
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant GE HEALTHCARE 9900 Innovation Drive Wauwatosa,  WI  53226
ContactBryan Behn
CorrespondentBryan Behn
GE HEALTHCARE 9900 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 Received2010-07-06
Decision Date2010-08-31
Summary:summary

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