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FDA 510(k) Application Details - K092477
Device Classification Name
Reduced- Montage Standard Electroencephalograph
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510(K) Number
K092477
Device Name
Reduced- Montage Standard Electroencephalograph
Applicant
NEUROWAVE SYSTEMS, INC.
2490 LEE BLVD.
SUITE 300
CLEVELAND HEIGHTS, OH 44118 US
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Contact
TRACIE CAPOZZIO
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Regulation Number
882.1400
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Classification Product Code
OMC
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More FDA Info for this Product Code
Date Received
08/12/2009
Decision Date
10/29/2010
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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