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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 K060065
Device Name CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR
Applicant
Oridion Capnography, Inc.
Har Hotzvim Sci Based Ind Pk
Pob 45025
Jerusalem,  IL 91450
Applicant Contact SANFORD BROWN
Correspondent
Oridion Capnography, Inc.
Har Hotzvim Sci Based Ind Pk
Pob 45025
Jerusalem,  IL 91450
Correspondent Contact SANFORD BROWN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/09/2006
Decision Date 05/04/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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