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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 K914862
Device Name CEREBROVASCULAR DIAGNOSTIC SYSTEM; CDS
Applicant
Medasonics, Inc.
47233 Fremont Blvd.
P.O. Box 4903
Fremont,  CA  94538
Applicant Contact KEITH V ROHRBACH
Correspondent
Medasonics, Inc.
47233 Fremont Blvd.
P.O. Box 4903
Fremont,  CA  94538
Correspondent Contact KEITH V ROHRBACH
Regulation Number892.1550
Classification Product Code
IYN  
Date Received10/29/1991
Decision Date 12/03/1992
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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