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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 K072266
Device Name ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
Mountain View,  CA  94039 -7393
Applicant Contact SHEILA PICKERING
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1570
Classification Product Code
ITX  
Subsequent Product Codes
IYN   IYO  
Date Received08/15/2007
Decision Date 08/29/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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