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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 K131164
Device Name ACUSON
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
1230 SHOREBIRD WAY
MOUNTAIN VIEW,  CA  94043
Applicant Contact SHELLY PEARCE
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
1230 SHOREBIRD WAY
MOUNTAIN VIEW,  CA  94043
Correspondent Contact SHELLY PEARCE
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   OBJ  
Date Received04/24/2013
Decision Date 12/24/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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