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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 K902515
Device Name ACUSON S228 TRANSDUCER FOR TRANSCRANIAL COLOR DOPP
Applicant
Acuson Corp.
1220 Charleston Rd.
Mountain View,  CA  94039
Applicant Contact STEPHEN T JOHNSON
Correspondent
Acuson Corp.
1220 Charleston Rd.
Mountain View,  CA  94039
Correspondent Contact STEPHEN T JOHNSON
Regulation Number892.1570
Classification Product Code
ITX  
Date Received06/05/1990
Decision Date 09/04/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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