GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM

System, Imaging, Pulsed Echo, Ultrasonic

GE MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Ge Logiq 500 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK970901
510k NumberK970901
Device Name:GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant GE MEDICAL SYSTEMS PO BOX 414 Milwaukee,  WI  53201
ContactDavid Duersteler
CorrespondentDavid Duersteler
GE MEDICAL SYSTEMS PO BOX 414 Milwaukee,  WI  53201
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-03-11
Decision Date1997-12-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682117371 K970901 000
00840682117265 K970901 000

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