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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 K911200
Device Name SI-1200 / ILUS
Applicant
Siemens Ultrasound, Inc.
2527 Camino Ramon, Suite 100
San Ramon,  CA  94583
Applicant Contact RICHARD JANOSKO
Correspondent
Siemens Ultrasound, Inc.
2527 Camino Ramon, Suite 100
San Ramon,  CA  94583
Correspondent Contact RICHARD JANOSKO
Regulation Number892.1560
Classification Product Code
IYO  
Date Received03/19/1991
Decision Date 06/17/1991
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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