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FDA 510(k) Application Details - K030489
Device Classification Name
Non-Normalizing Quantitative Electroencephalograph Software
More FDA Info for this Device
510(K) Number
K030489
Device Name
Non-Normalizing Quantitative Electroencephalograph Software
Applicant
BRAINZ INSTRUMENTS LTD.
25 CARBINE ROAD MT. WELLINGTON
PO BOX 51-078, PARURANGA
AUCKLAND NZ
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Contact
CHRIS MANDER
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Regulation Number
882.1400
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Classification Product Code
OLT
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More FDA Info for this Product Code
Date Received
02/14/2003
Decision Date
05/02/2003
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
Y
Expedited Review
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