FDA 510(k) Application Details - K060584

Device Classification Name Device, Nerve Conduction Velocity Measurement

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510(K) Number K060584
Device Name Device, Nerve Conduction Velocity Measurement
Applicant NEUROMETRIX, INC.
62 FOURTH AVE.
WALTHAM, MA 02451 US
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Contact RAINER N MAAS
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Regulation Number 882.1550

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Classification Product Code JXE
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Date Received 03/07/2006
Decision Date 07/31/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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