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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 K123622
Device Name ACUSON
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA INC.
685 east middlefield road
mountain view,  CA  94043 -0000
Original Contact patrick lynch
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   OBJ  
Date Received11/23/2012
Decision Date 12/05/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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