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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 K082142
Device Name ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
1230 shorebird way
mountain view,  CA  94043
Original Contact shelly pearce
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/30/2008
Decision Date 11/13/2008
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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