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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K013845
Device Name MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE
Applicant
ORIDION MEDICAL 1987 LTD.
7 HAMARPE ST. P.O. BOX 45025
HAR HOTZVIM INDUSTRIAL PARK
JERUSALEM,  IL 91450
Applicant Contact SANFORD BROWN
Correspondent
ORIDION MEDICAL 1987 LTD.
7 HAMARPE ST. P.O. BOX 45025
HAR HOTZVIM INDUSTRIAL PARK
JERUSALEM,  IL 91450
Correspondent Contact SANFORD BROWN
Regulation Number868.1400
Classification Product Code
CCK  
Date Received11/20/2001
Decision Date 11/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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