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FDA 510(k) Application Details - K983072
Device Classification Name
Standard Polysomnograph With Electroencephalograph
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510(K) Number
K983072
Device Name
Standard Polysomnograph With Electroencephalograph
Applicant
NIHON KOHDEN AMERICA, INC.
2601 CAMPUS DR.
IRVINE, CA 92612-1601 US
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Contact
GARY REASONER
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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
09/02/1998
Decision Date
12/01/1998
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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