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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Auditory, Evoked Response
510(k) Number K011746
Device Name MB 11
Applicant
Maico Diagnostic GmbH
9675 W. 76th St.
Eden Prairie,  MN  55344
Applicant Contact DANIEL E EGGAN
Correspondent
Maico Diagnostic GmbH
9675 W. 76th St.
Eden Prairie,  MN  55344
Correspondent Contact DANIEL E EGGAN
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received06/06/2001
Decision Date 08/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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