FDA 510(k) Application Details - K213518

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

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510(K) Number K213518
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant Covidien llc
6135 Gunbarrel Ave
Boulder, CO 80301 US
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Contact Inna Reznikov
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Regulation Number 868.1400

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Classification Product Code CCK
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Date Received 11/03/2021
Decision Date 04/12/2022
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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