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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 K982566
Device Name AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)
Applicant
BAR - ADVANCED CONTROL SYSTEMS LTD.
P.O. BOX 454
GINOT SHOMRON,  IL 44853
Applicant Contact AHAVA STEIN
Correspondent
BAR - ADVANCED CONTROL SYSTEMS LTD.
P.O. BOX 454
GINOT SHOMRON,  IL 44853
Correspondent Contact AHAVA STEIN
Regulation Number874.1050
Classification Product Code
EWO  
Date Received07/23/1998
Decision Date 10/21/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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