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510(k) K040113

SANDMAN SD20 AMPLIFIER by Eb Neuro S.P.A. — Product Code GWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2004
Date Received
January 20, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier, Physiological Signal
Device Class
Class II
Regulation Number
882.1835
Review Panel
NE
Submission Type

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