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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 K003508
Device Name NC-STAT
Applicant
Neurometrix, Inc.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact JAMES R VEALE
Correspondent
Neurometrix, Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact JAMES R VEALE
Regulation Number882.1550
Classification Product Code
JXE  
Date Received11/14/2000
Decision Date 01/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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