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 IDK122387
510k NumberK122387
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-06
Decision Date2012-09-11
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.