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FDA 510(k) Application Details - K083371
Device Classification Name
Stimulator, Electrical, Evoked Response
More FDA Info for this Device
510(K) Number
K083371
Device Name
Stimulator, Electrical, Evoked Response
Applicant
NATUS MEDICAL, INC.
ONE BIO-LOGIC PLAZA
MUNDELEIN, IL 60060 US
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Contact
NICOHL R WILDING
Other 510(k) Applications for this Contact
Regulation Number
882.1870
More FDA Info for this Regulation Number
Classification Product Code
GWF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/14/2008
Decision Date
12/08/2009
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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