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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 K980327
Device Name MICROSTREAM FILTERLINE ICU
Applicant
ORIDION MEDICAL LTD.
P.O. BOX 45025
JERUSALEM,  IL 91450
Applicant Contact SANFORD BROWN
Correspondent
ORIDION MEDICAL LTD.
P.O. BOX 45025
JERUSALEM,  IL 91450
Correspondent Contact SANFORD BROWN
Regulation Number868.1400
Classification Product Code
CCK  
Date Received01/28/1998
Decision Date 04/16/1998
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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