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FDA 510(k) Application Details - K173936
Device Classification Name
Stimulator, Photic, Evoked Response
More FDA Info for this Device
510(K) Number
K173936
Device Name
Stimulator, Photic, Evoked Response
Applicant
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)
2568 Bristol Circle
Oakville l6h 5s1 CA
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Contact
Sanjay Mehta
Other 510(k) Applications for this Contact
Regulation Number
882.1890
More FDA Info for this Regulation Number
Classification Product Code
GWE
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More FDA Info for this Product Code
Date Received
12/26/2017
Decision Date
06/15/2018
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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