FDA 510(k) Application Details - K030517

Device Classification Name Electrode, Nasopharyngeal

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510(K) Number K030517
Device Name Electrode, Nasopharyngeal
Applicant VIASYS HEALTHCARE, INC.
800 LEVANGER LN.
STOUGHTON, WI 53589 US
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Contact Gary Syring
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Regulation Number 882.1340

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Classification Product Code GZK
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Date Received 02/19/2003
Decision Date 08/01/2003
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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