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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 K926439
Device Name MA25 - PORTABLE AUDIOMETER, MODIFICATION
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 Number874.1050
Classification Product Code
EWO  
Date Received12/23/1992
Decision Date 08/05/1993
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
Predetermined Change
Control Plan Authorized		 No
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