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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 K903143
Device Name OTOSCREENER-I AND OTO-SCREEN-I-P
Applicant
Handtronix, Inc.
2435 Falcon Way
Sandy,  UT  84093
Applicant Contact LYNN S ALVORD
Correspondent
Handtronix, Inc.
2435 Falcon Way
Sandy,  UT  84093
Correspondent Contact LYNN S ALVORD
Regulation Number874.1050
Classification Product Code
EWO  
Date Received07/18/1990
Decision Date 09/19/1990
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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