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 IDK160162
510k NumberK160162
Device Name:Voluson P6, Voluson P8
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant GE HEALTHCARE 9900 W INNOVATION DR Wauwatosa,  WI  53226
ContactTracey Ortiz
CorrespondentTracey Ortiz
GE HEALTHCARE 9900 W INNOVATION DR 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 Received2016-01-27
Decision Date2016-04-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682104166 K160162 000
00840682116527 K160162 000
00840682108553 K160162 000
00840682106870 K160162 000
00840682105255 K160162 000
00840682105026 K160162 000
00840682104968 K160162 000
00840682104326 K160162 000

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