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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 K874548
Device Name SIM 4000C
Applicant
Ote-Biomedica Elettronica S.P.A
Parexel International Corp.
55 Wheeler St.
Cambridge,  MA  02138
Applicant Contact ANN B SAYIGH
Correspondent
Ote-Biomedica Elettronica S.P.A
Parexel International Corp.
55 Wheeler St.
Cambridge,  MA  02138
Correspondent Contact ANN B SAYIGH
Regulation Number892.1560
Classification Product Code
IYO  
Date Received11/03/1987
Decision Date 04/18/1988
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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