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FDA 510(k) Application Details - K000068
Device Classification Name
Non-Normalizing Quantitative Electroencephalograph Software
More FDA Info for this Device
510(K) Number
K000068
Device Name
Non-Normalizing Quantitative Electroencephalograph Software
Applicant
COMPUMEDICS NEURO SCIENCE PTY LTD.
6470 RIVERVIEW TERRACE
MINNEAPOLIS, MN 55432 US
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Contact
CONSTANCE G BUNDY
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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
01/10/2000
Decision Date
03/13/2000
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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