Voluson E6, Voluson E8, 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 E6, Voluson E8, Voluson E10.

Pre-market Notification Details

Device IDK162269
510k NumberK162269
Device Name:Voluson E6, Voluson E8, Voluson E10
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant GE Healthcare 9900 Innovation Drive, Milwaukee County Research Park Wauwatosa,  WI  53226
ContactBryan Behn
CorrespondentBryan Behn
GE Healthcare 9900 Innovation Drive, Milwaukee County Research Park 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 Received2016-08-12
Decision Date2016-10-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682123945 K162269 000
00840682123938 K162269 000
00840682123907 K162269 000
00840682123891 K162269 000

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