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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 Echo, Ultrasonic
510(k) Number K072676
Device Name ACUSON X300 ULTRASOUND SYSTEM
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
1230 SHOREBIRD WAY
MOUNTAIN VIEW,  CA  94039 -7393
Applicant Contact MARTINA VOGT
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
1230 SHOREBIRD WAY
MOUNTAIN VIEW,  CA  94039 -7393
Correspondent Contact MARTINA VOGT
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
DQO   ITX   IYN  
Date Received09/21/2007
Decision Date 12/18/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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