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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 K934715
Device Name MODEL 222 CLINICAL AUDIOMETER
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 Number874.1050
Classification Product Code
EWO  
Date Received10/01/1993
Decision Date 05/10/1994
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
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