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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 doppler, ultrasonic
510(k) Number K010374
Device Name SONOSITE HAND-CARRIED ULTRASOUND SYSTEM
Applicant
SONOSITE,INC.
21919 30TH DRIVE SE.
BOTHELL,  WA  98021 -3904
Applicant Contact MICHAEL A HOFFMAN
Correspondent
TUV PRODUCT SERVICE, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Code
IYO  
Date Received02/07/2001
Decision Date 02/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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