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FDA 510(k) Application Details - K042315
Device Classification Name
Index-Generating Electroencephalograph Software
More FDA Info for this Device
510(K) Number
K042315
Device Name
Index-Generating Electroencephalograph Software
Applicant
DANMETER A/S
KILDEMOSEVEJ 13
ODENSE C DK-5000 DK
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Contact
HANNE NIELSEN
Other 510(k) Applications for this Contact
Regulation Number
882.1400
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Classification Product Code
OLW
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More FDA Info for this Product Code
Date Received
08/26/2004
Decision Date
01/21/2005
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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