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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 K072295
Device Name CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE
Applicant
Oridion Capnography, Inc.
Hamarpe 7
Jerusalem,  IL 91450
Applicant Contact RACHEL WEISSBROD
Correspondent
Oridion Capnography, Inc.
Hamarpe 7
Jerusalem,  IL 91450
Correspondent Contact RACHEL WEISSBROD
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
CCK  
Date Received08/16/2007
Decision Date 10/11/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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