FDA 510(k) Application Details - K030907

Device Classification Name Stimulator, Auditory, Evoked Response

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510(K) Number K030907
Device Name Stimulator, Auditory, Evoked Response
Applicant BIO-LOGIC SYSTEMS CORP.
ONE BIO-LOGIC PLAZA
MUNDELEIN, IL 60060-3700 US
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Contact NORMAN E BRUNNER
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Regulation Number 882.1900

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Classification Product Code GWJ
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Date Received 03/24/2003
Decision Date 05/09/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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