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FDA 510(k) Application Details - K133517
Device Classification Name
Amplifier, Physiological Signal
More FDA Info for this Device
510(K) Number
K133517
Device Name
Amplifier, Physiological Signal
Applicant
EB NEURO, S.P.A.
9001 WESLEYAN RD, STE 200
INDIANAPOLIS, IN 46268 US
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Contact
ALLISON SCOTT, RAC
Other 510(k) Applications for this Contact
Regulation Number
882.1835
More FDA Info for this Regulation Number
Classification Product Code
GWL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/15/2013
Decision Date
02/26/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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