VOLUSON S6, VOLUSON S8

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 S6, Voluson S8.

Pre-market Notification Details

Device IDK141639
510k NumberK141639
Device Name:VOLUSON S6, VOLUSON S8
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 Received2014-06-19
Decision Date2014-07-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682118545 K141639 000
00840682118538 K141639 000
00840682118514 K141639 000
00840682118477 K141639 000

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