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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 K133517
Device Name NEMUS 2 SYSTEM
Applicant
Eb Neuro S.P.A.
9001 Wesleyan Rd.
Suite 200
Indianpolis,  IN  46268
Applicant Contact ALLISON SCOTT, RAC
Correspondent
Eb Neuro S.P.A.
9001 Wesleyan Rd.
Suite 200
Indianpolis,  IN  46268
Correspondent Contact ALLISON SCOTT, RAC
Regulation Number882.1835
Classification Product Code
GWL  
Subsequent Product Codes
GWE   GWF   GWJ  
Date Received11/15/2013
Decision Date 02/26/2014
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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