FDA 510(k) Application Details - K061908

Device Classification Name Electroencephalograph

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510(K) Number K061908
Device Name Electroencephalograph
Applicant VIASYS NEUROCARE
800 LEVANGER LANE
STOUGHTON, WI 53589 US
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Contact Gary Syring
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Regulation Number 882.1400

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Classification Product Code GWQ
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Date Received 07/05/2006
Decision Date 11/06/2006
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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