VOLUSON P6, VOLUSON P8

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 P6, Voluson P8.

Pre-market Notification Details

Device IDK141675
510k NumberK141675
Device Name:VOLUSON P6, VOLUSON P8
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 Received2014-06-25
Decision Date2014-07-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682118507 K141675 000
00840682118484 K141675 000
00840682108508 K141675 000

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