SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES)

System, Imaging, Pulsed Doppler, Ultrasonic

SONOSITE,INC.

The following data is part of a premarket notification filed by Sonosite,inc. with the FDA for Sonosite Hand-carried Ultrasound System (c2 Series).

Pre-market Notification Details

Device IDK023957
510k NumberK023957
Device Name:SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES)
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SONOSITE,INC. 21919 30TH DRIVE SE. Bothell,  WA  98021 -3904
ContactMichael A Hoffman
CorrespondentMark Job
TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton,  MN  55112 -1891
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2002-11-27
Decision Date2002-12-12
Summary:summary

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