Voluson E10

System, Imaging, Pulsed Doppler, Ultrasonic

GE Healthcare

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Voluson E10.

Pre-market Notification Details

Device IDK201768
510k NumberK201768
Device Name:Voluson E10
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant GE Healthcare 9900 Innovation Drive Wauwatosa,  WI  53095
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-29
Decision Date2020-10-22

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