Fujifilm Sonosite Vevo MD Imaging System

System, Imaging, Pulsed Doppler, Ultrasonic

FUJIFILM SONOSITE, INC.

The following data is part of a premarket notification filed by Fujifilm Sonosite, Inc. with the FDA for Fujifilm Sonosite Vevo Md Imaging System.

Pre-market Notification Details

Device IDK160674
510k NumberK160674
Device Name:Fujifilm Sonosite Vevo MD Imaging System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant FUJIFILM SONOSITE, INC. 21919 30TH DRIVE SE Bothell,  WA  98021 -3904
ContactScott Paulson
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2016-03-10
Decision Date2016-04-19
Summary:summary

NIH GUDID Devices

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