TITAN HIGH RESOLUTION ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

SONOSITE,INC.

The following data is part of a premarket notification filed by Sonosite,inc. with the FDA for Titan High Resolution Ultrasound System.

Pre-market Notification Details

Device IDK030949
510k NumberK030949
Device Name:TITAN HIGH RESOLUTION ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SONOSITE,INC. 21919 30TH DRIVE SE. Bothell,  WA  98021 -3904
ContactMichael Hoffman
CorrespondentLaura Danielson
TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton,  MN  55112 -1891
Product CodeIYN  
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2003-03-26
Decision Date2003-04-07
Summary:summary

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