FDA 510(k) Application Details - K973883

Device Classification Name Electroencephalograph

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510(K) Number K973883
Device Name Electroencephalograph
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 882.1400

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Classification Product Code GWQ
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Date Received 10/14/1997
Decision Date 03/05/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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