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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 K042055
Device Name CYPRESS ULTRASOUND SYSTEM
Applicant
Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P O Box 7393
Mountain View,  CA  94039 -7393
Applicant Contact PATRICK LYNCH
Correspondent
Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P O Box 7393
Mountain View,  CA  94039 -7393
Correspondent Contact PATRICK LYNCH
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/30/2004
Decision Date 08/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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