FDA 510(k) Application Details - K031741

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

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510(K) Number K031741
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant ALARIS MEDICAL SYSTEMS, INC.
10221 WATERIDGE CIR.
SAN DIEGO, CA 92121 US
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Contact RENEE L FLUET
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Regulation Number 868.1400

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Classification Product Code CCK
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Date Received 06/04/2003
Decision Date 02/09/2004
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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