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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 K082098
Device Name SONOSITE MAXX SERIES ULTRASOUND SYSTEM
Original Applicant
SONOSITE,INC.
21919 30th drive se.
bothell,  WA  98021 3904
Original Contact christopher j hartzog
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   LLZ  
Date Received07/25/2008
Decision Date 08/25/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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