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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 K040113
Device Name SANDMAN SD20 AMPLIFIER
Applicant
EB NEURO, S.P.A.
7992 CASTLEWAY DR.
INDIANAPOLIS,  IN  46250
Applicant Contact COLLEEN DENSMORE
Correspondent
EB NEURO, S.P.A.
7992 CASTLEWAY DR.
INDIANAPOLIS,  IN  46250
Correspondent Contact COLLEEN DENSMORE
Regulation Number882.1835
Classification Product Code
GWL  
Date Received01/20/2004
Decision Date 02/18/2004
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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