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510(k) K003154

MIZAR, BASIS BE, SANDMAN DIGITAL by Eb Neuro S.P.A. — Product Code GWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2001
Date Received
October 10, 2000
Clearance Type
Traditional
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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