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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 K000565
Device Name MODIFICATION TO NC-STAT
Applicant
NEUROMETRIX, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact CYNTHIA J.M. NOLTE
Correspondent
NEUROMETRIX, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact CYNTHIA J.M. NOLTE
Regulation Number882.1550
Classification Product Code
JXE  
Date Received02/22/2000
Decision Date 06/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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