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FDA 510(k) Application Details - K200594
Device Classification Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
868.1400
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Classification Product Code
CCK
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More FDA Info for this Product Code
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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