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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, imaging, pulsed echo, ultrasonic
510(k) Number K113156
Device Name SONOSITE EDGE ULTRASOUND SYSTEM
Applicant
SONOSITE,INC.
21919 30TH DRIVE SE.
BOTHELL,  WA  98021 -3904
Applicant Contact SCOTT PAULSON
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN   LLZ  
Date Received10/26/2011
Decision Date 11/15/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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