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FDA 510(k) Application Details - K012395
Device Classification Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
More FDA Info for this Device
510(K) Number
K012395
Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant
ORIDION MEDICAL 1987 LTD.
7 HAMARPE ST. P.O. BOX 45025
HAR HOTZVIM INDUSTRIAL PARK
JERUSALEM 91450 IL
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Contact
SANFORD BROWN
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
07/27/2001
Decision Date
08/15/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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