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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transducer, ultrasonic, diagnostic
510(k) Number K121807
Device Name V5MS TRANSDUCER
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
685 east middlefield road
mountain view,  CA  94043
Original Contact shelly pearce
Regulation Number892.1570
Classification Product Code
ITX  
Date Received06/20/2012
Decision Date 07/10/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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