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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.
NO.5, LANE116, WU-KONG 2ND RD
NEW TAIPEI CITY,  TW TAIWAN
Applicant Contact WINNIE CHUNG
Correspondent
BESMED HEALTH BUSINESS CORP.
NO.5, LANE116, 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
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