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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 K914232
Device Name ASRA, SCREENING AUDIOMETER
Applicant
Mercury Electronics (Scot) , Ltd.
Pollok Castle Estate
Newton Mearns
Glasgow 577 6nu U.K.,  GB
Applicant Contact ERIC W GREIG
Correspondent
Mercury Electronics (Scot) , Ltd.
Pollok Castle Estate
Newton Mearns
Glasgow 577 6nu U.K.,  GB
Correspondent Contact ERIC W GREIG
Regulation Number874.1050
Classification Product Code
EWO  
Date Received09/20/1991
Decision Date 01/31/1992
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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