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FDA 510(k) Application Details - K000898
Device Classification Name
Electroencephalograph
More FDA Info for this Device
510(K) Number
K000898
Device Name
Electroencephalograph
Applicant
EXCEL TECH. LTD.
2568 BRISTOL CIRCLE
OAKVILLE, ONTARIO L6H 5S1 CA
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Contact
DEBBIE DAVY
Other 510(k) Applications for this Contact
Regulation Number
882.1400
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Classification Product Code
GWQ
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More FDA Info for this Product Code
Date Received
03/21/2000
Decision Date
04/14/2000
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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