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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K863984
Device Name MODEL 320 TWO CHANNEL AUDIOMETER
Applicant
Virtual Corp.
P.O. Box 8885
Portland,  OR  97207
Applicant Contact JONATHAN D BIRCK
Correspondent
Virtual Corp.
P.O. Box 8885
Portland,  OR  97207
Correspondent Contact JONATHAN D BIRCK
Regulation Number874.1050
Classification Product Code
EWO  
Date Received10/14/1986
Decision Date 11/18/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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