FDA 510(k) Application Details - K040554

Device Classification Name Electroencephalograph

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510(K) Number K040554
Device Name Electroencephalograph
Applicant MANUFACTURING TECHNOLOGY, INC.
70 READY AVE., N.W.
FORT WALTON BEACH, FL 32548 US
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Contact JOHN G SCHNEIDER
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Regulation Number 882.1400

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Classification Product Code GWQ
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Date Received 03/02/2004
Decision Date 07/16/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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