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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
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
1230 SHOREBIRD WAY
MOUNTAIN VIEW,  CA  94039 -7393
Applicant Contact SHELLY PEARCE
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1550
Classification Product Code
IYN  
Date Received07/19/2010
Decision Date 09/20/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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