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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 K080760
Device Name ACUSON X300 ULTRASOUND SYSTEM
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
1230 SHOREBIRD WAY
MOUNTAIN VIEW,  CA  94043
Applicant Contact MARTINA VOGT
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
1230 SHOREBIRD WAY
MOUNTAIN VIEW,  CA  94043
Correspondent Contact MARTINA VOGT
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
DQO   ITX   IYO  
Date Received03/18/2008
Decision Date 04/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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