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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 K905704
Device Name MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER
Applicant
Maico Hearing Instruments, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Applicant Contact LOIS DONNAY
Correspondent
Maico Hearing Instruments, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Correspondent Contact LOIS DONNAY
Regulation Number874.1090
Classification Product Code
ETY  
Date Received12/21/1990
Decision Date 04/30/1991
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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