SONOSITE EDGE ULTRASOUND SYSTEM

System, Imaging, Pulsed Echo, Ultrasonic

SONOSITE,INC.

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

Pre-market Notification Details

Device IDK113156
510k NumberK113156
Device Name:SONOSITE EDGE ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant 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 CodeIYO  
Subsequent Product CodeITX
Subsequent Product CodeIYN
Subsequent Product CodeLLZ
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-10-26
Decision Date2011-11-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841517105754 K113156 000
00841517106447 K113156 000
00841517107598 K113156 000
00841517107628 K113156 000
00841517108113 K113156 000
00841517106829 K113156 000
00841517109585 K113156 000
00841517110369 K113156 000
00841517110352 K113156 000

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