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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 K904017
Device Name SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES
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 Number892.1550
Classification Product Code
IYN  
Date Received08/30/1990
Decision Date 03/21/1991
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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