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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tester, auditory impedance
510(k) Number K930164
Device Name THE AUTOMATIC IMPEDANCE METER,MODEL AE-208D/S
Applicant
AMERICAN ELECTROMEDICS CORP.
13 COLUMBUS DR.
SUITE 18
AMHERST,  NH  03031
Applicant Contact NOEL WREN
Correspondent
AMERICAN ELECTROMEDICS CORP.
13 COLUMBUS DR.
SUITE 18
AMHERST,  NH  03031
Correspondent Contact NOEL WREN
Regulation Number874.1090
Classification Product Code
ETY  
Date Received01/13/1993
Decision Date 04/23/1993
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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