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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
Recalls CDRH Recalls
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