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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Auditory, Evoked Response
510(k) Number K926574
Device Name MODEL 330 SCREENING AUDIO METER, MODIFIED
Applicant
Virtual Corp.
521 SW 11th
Suite 400
Portland,  OR  97205
Applicant Contact JONATHAN D BIRCK
Correspondent
Virtual Corp.
521 SW 11th
Suite 400
Portland,  OR  97205
Correspondent Contact JONATHAN D BIRCK
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received12/30/1992
Decision Date 03/29/1993
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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