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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 K082035
Device Name MAICO MB 11 WITH BERAPHONE PROBE
Applicant
Maico Diagnostics
7625 Golden Triangle Dr.
Minnesota,  MN  55344
Applicant Contact DANIEL EGGAN
Correspondent
Maico Diagnostics
7625 Golden Triangle Dr.
Minnesota,  MN  55344
Correspondent Contact DANIEL EGGAN
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received07/17/2008
Decision Date 01/29/2009
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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