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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K890055
Device Name ACUSON S228 TRANSDUCER FOR TRANSCRANIAL DOPPLER
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 Number892.1550
Classification Product Code
IYN  
Date Received01/06/1989
Decision Date 05/16/1989
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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