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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 K033196
Device Name SONOLINE ANTARES WITH CLARIFY VE
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
22010 S.E. 51ST ST.
ISSAQUAH,  WA  98029 -7298
Applicant Contact JUDI HOFFMAN
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  
Subsequent Product Codes
ITX   IYO  
Date Received10/02/2003
Decision Date 10/16/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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