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FDA 510(k) Application Details - K100683
Device Classification Name
Electroencephalograph
More FDA Info for this Device
510(K) Number
K100683
Device Name
Electroencephalograph
Applicant
NATUS MEDICAL INCORPORATED
DBA EXCEL-TECH LTD (XLTEK)
2568 BRISTOL CIRCLE
OAKVILLE, ONTARIO L6H 5S1 CA
Other 510(k) Applications for this Company
Contact
GOLDY SINGH
Other 510(k) Applications for this Contact
Regulation Number
882.1400
More FDA Info for this Regulation Number
Classification Product Code
GWQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/10/2010
Decision Date
04/09/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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