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FDA 510(k) Application Details - K172711
Device Classification Name
Standard Polysomnograph With Electroencephalograph
More FDA Info for this Device
510(K) Number
K172711
Device Name
Standard Polysomnograph With Electroencephalograph
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
882.1400
More FDA Info for this Regulation Number
Classification Product Code
OLV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/08/2017
Decision Date
11/03/2017
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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