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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 K121927
Device Name MICROSTREAM FILTERLINE ICU
Original Applicant
ORIDION MEDICAL 1987 LTD.
7 hamarpe st. p.o. box 45025
har hotzvim industrial park
jerusalem,  IL 91450
Original Contact dalia givony
Regulation Number868.1400
Classification Product Code
CCK  
Date Received07/02/2012
Decision Date 11/29/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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