FDA 510(k) Application Details - K052904

Device Classification Name Device, Nerve Conduction Velocity Measurement

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510(K) Number K052904
Device Name Device, Nerve Conduction Velocity Measurement
Applicant SCIENTIFIC IMAGING, INC.
110 BASCOMB DRIVE
WOODSTOCK, GA 30189 US
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Contact CHRIS JOHNSON
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Regulation Number 882.1550

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Classification Product Code JXE
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Date Received 10/14/2005
Decision Date 10/27/2005
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 Y
Expedited Review

FDA Source Information for K052904


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