FDA 510(k) Application Details - K024300

Device Classification Name Oximeter

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510(K) Number K024300
Device Name Oximeter
Applicant ORIDION MEDICAL 1987 LTD.
7 HAMARPE ST. P.O. BOX 45025
HAR HOTZVIM INDUSTRIAL PARK
JERUSALEM 91450 IL
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Contact SANDY BROWN
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 12/24/2002
Decision Date 04/03/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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