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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 K891449
Device Name SONOLINE CF
Applicant
Siemens Ultrasound, Inc.
5675 Gibraltar Dr.
Pleasanton,  CA  94566
Applicant Contact K JOHNSON
Correspondent
Siemens Ultrasound, Inc.
5675 Gibraltar Dr.
Pleasanton,  CA  94566
Correspondent Contact K JOHNSON
Regulation Number892.1560
Classification Product Code
IYO  
Date Received03/15/1989
Decision Date 10/05/1989
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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