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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 K033367
Device Name TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L03073, L02245, L02464
Applicant
SONOSITE,INC.
21919 30TH DRIVE SE.
BOTHELL,  WA  98021 -3904
Applicant Contact MICHAEL A HOFFMAN
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received10/21/2003
Decision Date 11/05/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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