FDA 510(k) Application Details - K003508

Device Classification Name Device, Nerve Conduction Velocity Measurement

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510(K) Number K003508
Device Name Device, Nerve Conduction Velocity Measurement
Applicant NEUROMETRIX, INC.
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
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Contact JAMES R VEALE
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Regulation Number 882.1550

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Classification Product Code JXE
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Date Received 11/14/2000
Decision Date 01/17/2001
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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