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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 K101995
Device Name CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD
Applicant
Oridion Capnography, Inc.
160 Gould St.
Needham,  MA  02494
Applicant Contact RACHEL WEISSBROD
Correspondent
Oridion Capnography, Inc.
160 Gould St.
Needham,  MA  02494
Correspondent Contact RACHEL WEISSBROD
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
CCK  
Date Received07/14/2010
Decision Date 01/11/2011
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
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