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FDA 510(k) Application Details - K003508
Device Classification Name
Device, Nerve Conduction Velocity Measurement
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
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
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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