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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 K132957
Device Name MADSEN ACCUSCREEN TYPE 1077
Applicant
GN OTOMETRICS
8870 RAVELLO CT
NAPLES,  FL  34114
Applicant Contact DANIEL KAMM, P.E.
Correspondent
GN OTOMETRICS
8870 RAVELLO CT
NAPLES,  FL  34114
Correspondent Contact DANIEL KAMM, P.E.
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received09/20/2013
Decision Date 02/27/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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