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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, cutaneous
510(k) Number K121816
Device Name SENSUS ELECTRODE
Original Applicant
NEUROMETRIX, INC.
62 fourth ave.
waltham,  MA  02451
Original Contact rainer maas
Regulation Number882.1320
Classification Product Code
GXY  
Date Received06/20/2012
Decision Date 11/26/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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