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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 K192446
Device Name CO2 Mainstream Module
Applicant
Beijing Kingst Commercial & Trade Co., Ltd.
6th Floor Of #2-7,Rd. Beibinhe
Xibianmen
Beijing,  CN 100053
Applicant Contact Judong Gao
Correspondent
Irc
2950 E Lindrick Dr.
Chandler,  AZ  85249
Correspondent Contact Charlie Mack
Regulation Number868.1400
Classification Product Code
CCK  
Date Received09/06/2019
Decision Date 05/21/2020
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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