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510(k) K053606

BE PLUS / AURA-LTM64 AMPLIFIER by Eb Neuro S.P.A. — Product Code GWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2006
Date Received
December 27, 2005
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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