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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 K121996
Device Name BE PLUS LTM AMPLIFIER GWI AMPLIFIER
Applicant
EB NEURO, S.P.A.
9001 WESLEYAN ROAD
INDIANAPOLIS,  IN  46268
Applicant Contact Allison Scott
Correspondent
EB NEURO, S.P.A.
9001 WESLEYAN ROAD
INDIANAPOLIS,  IN  46268
Correspondent Contact Allison Scott
Regulation Number882.1835
Classification Product Code
GWL  
Date Received07/09/2012
Decision Date 08/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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