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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 -2029
Applicant Contact LOIS DONNAY
Correspondent
Maico Hearing Instruments, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439 -2029
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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