FDA 510(k) Application Details - K944314

Device Classification Name Electrode, Cutaneous

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510(K) Number K944314
Device Name Electrode, Cutaneous
Applicant BIO-LOGIC SYSTEMS CORP.
ONE BIO-LOGIC PLAZA
MUNDELEIN, IL 60060-3700 US
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Contact RON ROLFSEN
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Regulation Number 882.1320

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Classification Product Code GXY
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Date Received 08/29/1994
Decision Date 01/03/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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