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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 K921085
Device Name PROGRAMMED AUDIOMETRIC DEVICE (PAD)/RECORS (PAR)
Applicant
Hear-Well Technologies, Inc.
79 Lyon Ave.
Guelph,  CA N1H 5C7
Applicant Contact WAYNE GATEHOUSE
Correspondent
Hear-Well Technologies, Inc.
79 Lyon Ave.
Guelph,  CA N1H 5C7
Correspondent Contact WAYNE GATEHOUSE
Regulation Number874.1050
Classification Product Code
EWO  
Date Received03/06/1992
Decision Date 05/15/1992
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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