FDA 510(k) Application Details - K990063

Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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510(K) Number K990063
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
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 868.1400

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Classification Product Code CCK
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Date Received 01/08/1999
Decision Date 06/09/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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