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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name amplifier, physiological signal
510(k) Number K083322
Device Name NEUROMETRIX BIOAMPLIFIER
Applicant
NEUROMETRIX, INC.
62 FOURTH AVE.
WALTHAM,  MA  02451
Applicant Contact RAINER MAAS
Correspondent
NEUROMETRIX, INC.
62 FOURTH AVE.
WALTHAM,  MA  02451
Correspondent Contact RAINER MAAS
Regulation Number882.1835
Classification Product Code
GWL  
Date Received11/12/2008
Decision Date 05/27/2009
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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