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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 K094012
Device Name CAPNOSTREAM20 WITH MICROMEDICO2 MODULE
Applicant
ORIDION CAPNOGRAPHY, INC.
160 GOULD STREET
NEEDHAM,  MA  02494
Applicant Contact RACHEL WEISSBROD
Correspondent
ORIDION CAPNOGRAPHY, INC.
160 GOULD STREET
NEEDHAM,  MA  02494
Correspondent Contact RACHEL WEISSBROD
Regulation Number868.1400
Classification Product Code
CCK  
Date Received12/29/2009
Decision Date 05/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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