FDA 510(k) Application Details - K010086

Device Classification Name Electroencephalograph

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510(K) Number K010086
Device Name Electroencephalograph
Applicant EXCEL TECH. LTD.
2568 BRISTOL CIRCLE
OAKVILLE, ONTARIO L6H 5S1 CA
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Contact SONJA MARKEZ
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Regulation Number 882.1400

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Classification Product Code GWQ
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Date Received 01/11/2001
Decision Date 04/09/2001
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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