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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 K003154
FOIA Releasable 510(k) K003154
Device Name MIZAR, BASIS BE, SANDMAN DIGITAL
Applicant
EB NEURO, S.P.A.
7992 CASTLEWAY DR.
INDIANAPOLIS,  IN  46250
Applicant Contact COLLEEN HITTLE
Correspondent
EB NEURO, S.P.A.
7992 CASTLEWAY DR.
INDIANAPOLIS,  IN  46250
Correspondent Contact COLLEEN HITTLE
Regulation Number882.1835
Classification Product Code
GWL  
Date Received10/10/2000
Decision Date 01/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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