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FDA 510(k) Application Details - K013459
Device Classification Name
Device, Nerve Conduction Velocity Measurement
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510(K) Number
K013459
Device Name
Device, Nerve Conduction Velocity Measurement
Applicant
NEUROMETRIX, INC.
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
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Contact
SHIELA HEMEON-HEYER
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Regulation Number
882.1550
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Classification Product Code
JXE
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More FDA Info for this Product Code
Date Received
10/18/2001
Decision Date
01/17/2002
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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