VIVID I DIAGNOSTIC ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

GE MEDICAL SYSTEM ISRAEL LTD.

The following data is part of a premarket notification filed by Ge Medical System Israel Ltd. with the FDA for Vivid I Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK102388
510k NumberK102388
Device Name:VIVID I DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant GE MEDICAL SYSTEM ISRAEL LTD. 9900 INNOVATION DR Wauwatosa,  WI  53226
ContactBryan Behn
CorrespondentBryan Behn
GE MEDICAL SYSTEM ISRAEL LTD. 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 Received2010-08-23
Decision Date2010-11-04
Summary:summary

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