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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 K040011
Device Name POLARIS 2004 CAPNOGRAPH
Applicant
Oridion , Ltd.
21 Highland Cir.
Needham,  MA  02494
Applicant Contact DOMINIC CORSALE
Correspondent
Oridion , Ltd.
21 Highland Cir.
Needham,  MA  02494
Correspondent Contact DOMINIC CORSALE
Regulation Number868.1400
Classification Product Code
CCK  
Date Received01/05/2004
Decision Date 05/13/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
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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