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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 Echo, Ultrasonic
510(k) Number K884632
Device Name ACUSON I5100 ULTRASOUND TRANSDUCER
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 Number892.1560
Classification Product Code
IYO  
Date Received11/07/1988
Decision Date 01/13/1989
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
Recalls CDRH Recalls
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