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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 K102017
Device Name SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
1230 shorebird way
mountain view,  CA  94039 7393
Original Contact shelly pearce
Regulation Number892.1550
Classification Product Code
IYN  
Date Received07/19/2010
Decision Date 09/20/2010
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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