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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
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