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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 K192488
Device Name CO2 Sidestream Module
Beijing Kingst Commercial & Trade Co.,Ltd.
6th Floor of No.2-7,Road Beibinhe
Beijing,  CN 100053
Applicant Contact Judong Gao
2950 E Lindrick Drive
Chandler,  AZ  85249
Correspondent Contact Charlie Mack
Regulation Number868.1400
Classification Product Code
Date Received09/11/2019
Decision Date 05/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No