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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 K060879
Device Name MODEL EC9-4 TRANSDUCER
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
1230 SHOREBIRD WAY
P O BOX 7393
MOUNTAIN VIEW,  CA  94039 -7393
Applicant Contact PATRICK LYNCH
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
1230 SHOREBIRD WAY
P O BOX 7393
MOUNTAIN VIEW,  CA  94039 -7393
Correspondent Contact PATRICK LYNCH
Regulation Number892.1570
Classification Product Code
ITX  
Date Received03/31/2006
Decision Date 04/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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