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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 K221118
Device Name CO2 Mainstream Sensor
Applicant
Draegerwerk AG & CO Kgaa
53/55 Moislinger Allee
Luebeck,  DE 23542
Applicant Contact Lyubov Lange
Correspondent
Draegerwerk AG & CO Kgaa
53/55 Moislinger Allee
Luebeck,  DE 23542
Correspondent Contact Lyubov Lange
Regulation Number868.1400
Classification Product Code
CCK  
Date Received04/18/2022
Decision Date 04/05/2023
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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