FDA 510(k) Application Details - K093388

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

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510(K) Number K093388
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant ORIDION MEDICAL 1987 LTD.
7 HAMARPE ST. P.O.B. 45025
HAR HOTZVIM INDUSTRIAL PARK
JERUSALEM 91450 IL
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Contact RACHEL WEISSBROD
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Regulation Number 868.1400

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Classification Product Code CCK
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Date Received 10/30/2009
Decision Date 03/04/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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