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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 K111674
Model S2000
Device Name ACUSON
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
1230 shorebird way
mountain view,  CA  94043 1344
Original Contact shelly pearce
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   OBJ  
Date Received06/15/2011
Decision Date 06/30/2011
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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