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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 K905212
Device Name IMMITTANCE METER, MODEL AE-105D/S
Applicant
American Electromedics Corp.
13 Sagamore Park Rd.
Hudson,  NH  03051
Applicant Contact THOMAS M GLEASON
Correspondent
American Electromedics Corp.
13 Sagamore Park Rd.
Hudson,  NH  03051
Correspondent Contact THOMAS M GLEASON
Regulation Number874.1090
Classification Product Code
ETY  
Date Received11/20/1990
Decision Date 02/19/1991
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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