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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 K041198
Device Name NIC36 AMPLIFIER
Applicant
EB NEURO, S.P.A.
7992 CASTLEWAY DRIVE
INDIANAPOLIS,  IN  46250
Applicant Contact CARRI GRAHAM
Correspondent
EB NEURO, S.P.A.
7992 CASTLEWAY DRIVE
INDIANAPOLIS,  IN  46250
Correspondent Contact CARRI GRAHAM
Regulation Number882.1835
Classification Product Code
GWL  
Date Received05/07/2004
Decision Date 06/01/2004
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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