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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 K143127
Device Name CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style
Applicant
Dispo-Med (Malaysia) Sdn Bhd
21, Jalan Teknologi 3/5a, Pusat Teknologi Sinar Damansara,
Kota Damansara
Petaling Jaya , Selangor Darul Ehsan,  MY 47810
Applicant Contact NC LEOW
Correspondent
Dispo-Med (Malaysia) Sdn Bhd
21, Jalan Teknologi 3/5a, Pusat Teknologi Sinar Damansara,
Kota Damansara
Petaling Jaya , Selangor Darul Ehsan,  MY 47810
Correspondent Contact PAUL DRYDEN
Regulation Number868.1400
Classification Product Code
CCK  
Date Received10/31/2014
Decision Date 02/13/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
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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