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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 K133516
Device Name CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER
Applicant
FLEXICARE
CYNON VALLEY BUSINESS PARK
MOUNTAIN ASH
MID GLAM,  GB CF454ER
Applicant Contact CHRISTOPHER WATKINS
Correspondent
FLEXICARE
CYNON VALLEY BUSINESS PARK
MOUNTAIN ASH
MID GLAM,  GB CF454ER
Correspondent Contact CHRISTOPHER WATKINS
Regulation Number868.1400
Classification Product Code
CCK  
Date Received11/15/2013
Decision Date 04/30/2014
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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