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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 K143150
Device Name CO2 monitoring line with and without in-line filter
Applicant
Besmed Health Business Corp
#5, Ln.116, Wu-Kong 2nd Rd.
New Taipei City,  TW TAIWAN
Applicant Contact WINNIE CHUNG
Correspondent
Besmed Health Business Corp
#5, Ln.116, Wu-Kong 2nd Rd.
New Taipei City,  TW TAIWAN
Correspondent Contact PAUL DRYDEN
Regulation Number868.1400
Classification Product Code
CCK  
Date Received11/03/2014
Decision Date 02/05/2015
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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