FDA 510(k) Application Details - K973984

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

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510(K) Number K973984
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant MARQUETTE MEDICAL SYSTEMS, INC.
8200 WEST TOWER AVE.
MILWAUKEE, WI 53223 US
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Contact DIANNE SCHMITZ
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Regulation Number 868.1400

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Classification Product Code CCK
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Date Received 10/20/1997
Decision Date 01/16/1998
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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