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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 K112368
Device Name CAPNOSTREAM20P WITH AI/ODI
Applicant
ORIDION MEDICAL 1987 LTD.
7 HAMARPE STREET, HAR
HOTZVIM INDUSTRIAL PARK
JERUSALEM,  IL 91450
Applicant Contact RACHEL WEISSBROD
Correspondent
ORIDION MEDICAL 1987 LTD.
7 HAMARPE STREET, HAR
HOTZVIM INDUSTRIAL PARK
JERUSALEM,  IL 91450
Correspondent Contact RACHEL WEISSBROD
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Codes
DQA   MNR  
Date Received08/17/2011
Decision Date 07/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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