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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Nerve Conduction Velocity Measurement
510(k) Number K013459
Device Name MODIFICATION OF NC-STAT
Applicant
NEUROMETRIX, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact SHIELA HEMEON-HEYER
Correspondent
NEUROMETRIX, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact SHIELA HEMEON-HEYER
Regulation Number882.1550
Classification Product Code
JXE  
Date Received10/18/2001
Decision Date 01/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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