FDA 510(k) Application Details - K982479

Device Classification Name Electroencephalograph

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510(K) Number K982479
Device Name Electroencephalograph
Applicant EXCEL TECH. LTD.
2892 PORTLAND DR.
OAKVILLE,ONTARIO L6H 5W8 CA
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Contact JOHN R MUMFORD
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Regulation Number 882.1400

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Classification Product Code GWQ
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Date Received 07/16/1998
Decision Date 10/14/1998
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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