FDA 510(k) Application Details - K023454

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

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510(K) Number K023454
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant DATEX-OHMEDA
86 PILGRIM RD.
NEEDHAM, MA 02492 US
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Contact JOEL C KENT
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Regulation Number 868.1400

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Classification Product Code CCK
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Date Received 10/15/2002
Decision Date 04/23/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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