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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter
510(k) Number K082268
Device Name CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX
Applicant
ORIDION CAPNOGRAPHY, INC.
HAR HOTZVIM SCIENCE PARK
POB 45025
JERUSALEM,  IL 91450
Applicant Contact RACHEL WEISSBROD
Correspondent
ORIDION CAPNOGRAPHY, INC.
HAR HOTZVIM SCIENCE PARK
POB 45025
JERUSALEM,  IL 91450
Correspondent Contact RACHEL WEISSBROD
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
CCK  
Date Received08/11/2008
Decision Date 02/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT00659516
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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