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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 K060584
Device Name NC-STAT
Applicant
Neurometrix, Inc.
62 Fourth Ave.
Waltham,  MA  02451
Applicant Contact RAINER N MAAS
Correspondent
Neurometrix, Inc.
62 Fourth Ave.
Waltham,  MA  02451
Correspondent Contact RAINER N MAAS
Regulation Number882.1550
Classification Product Code
JXE  
Subsequent Product Code
IKN  
Date Received03/07/2006
Decision Date 07/31/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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