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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
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
685 East Middlefield Road
Mountain View,  CA  94043
Applicant Contact SHELLY PEARCE
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1570
Classification Product Code
ITX  
Date Received06/20/2012
Decision Date 07/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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