SONOSITE HAND-CARRIED 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 Sonosite Hand-carried Ultrasound System.

Pre-market Notification Details

Device IDK010374
510k NumberK010374
Device Name:SONOSITE HAND-CARRIED ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SONOSITE,INC. 21919 30TH DRIVE SE. Bothell,  WA  98021 -3904
ContactMichael A Hoffman
Product CodeIYN  
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2001-02-07
Decision Date2001-02-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.