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FDA 510(k) Application Details - K033475
Device Classification Name
Standard Polysomnograph With Electroencephalograph
More FDA Info for this Device
510(K) Number
K033475
Device Name
Standard Polysomnograph With Electroencephalograph
Applicant
NIHON KOHDEN AMERICA, INC.
90 ICON ST.
FOOTHILL RANCH, CA 92610-1601 US
Other 510(k) Applications for this Company
Contact
SERRAH NAMINI
Other 510(k) Applications for this Contact
Regulation Number
882.1400
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Classification Product Code
OLV
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More FDA Info for this Product Code
Date Received
11/03/2003
Decision Date
01/07/2004
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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