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FDA 510(k) Application Details - K031009
Device Classification Name
Stimulator, Auditory, Evoked Response
More FDA Info for this Device
510(K) Number
K031009
Device Name
Stimulator, Auditory, Evoked Response
Applicant
BIO-LOGIC SYSTEMS CORP.
ONE BIO-LOGIC PLAZA
MUNDELEIN, IL 60060-3700 US
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Contact
NORMAN E BRUNNER
Other 510(k) Applications for this Contact
Regulation Number
882.1900
More FDA Info for this Regulation Number
Classification Product Code
GWJ
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More FDA Info for this Product Code
Date Received
03/31/2003
Decision Date
04/28/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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