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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Auditory Impedance
510(k) Number K853863
Device Name MODEL 310 IMPEDANCE SYSTEM
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 Number874.1090
Classification Product Code
ETY  
Date Received09/17/1985
Decision Date 12/18/1985
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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