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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Echoencephalograph
510(k) Number K903085
Device Name SMS-712NA
Applicant
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781 -2068
Applicant Contact CHRISTOPHER M BOHL
Correspondent
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781 -2068
Correspondent Contact CHRISTOPHER M BOHL
Regulation Number882.1240
Classification Product Code
GXW  
Date Received07/12/1990
Decision Date 10/05/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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