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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
Applicant
Oridion Medical 1987 , Ltd.
7 Hamarpe St. P.O. Box 45025
Har Hotzvim Industrial Park
Jerusalem,  IL 91450
Applicant Contact DALIA GIVONY
Correspondent
Oridion Medical 1987 , Ltd.
7 Hamarpe St. P.O. Box 45025
Har Hotzvim Industrial Park
Jerusalem,  IL 91450
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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