SonoSite Edge II Ultrasound 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 Sonosite Edge Ii Ultrasound System.

Pre-market Notification Details

Device IDK153626
510k NumberK153626
Device Name:SonoSite Edge II Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant FUJIFILM SONOSITE,INC. 21919 30th Dr SE Bothell,  WA  98021 -3904
ContactPatricia Liau
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 Received2015-12-18
Decision Date2016-01-20
Summary:summary

NIH GUDID Devices

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