FDA 510(k) Application Details - K200594

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

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510(K) Number K200594
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant Oridion Medical 1987 Ltd.
7 Hamarpe St.
Jerusalem 9777407 IL
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Contact Lital David
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Regulation Number 868.1400

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Classification Product Code CCK
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Date Received 03/06/2020
Decision Date 04/27/2020
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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