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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
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