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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 K190824
Device Name Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric
Applicant
Bluepoint Medical GmbH & Co. KG
An Der Trave 15
Selmsdorf,  DE 23923
Applicant Contact Bernd Lindner
Correspondent
Imagenix, Inc.
S65w35739 Piper Rd.
Egale,  WI  53119
Correspondent Contact Stephen Gorski
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Code
CCL  
Date Received04/01/2019
Decision Date 12/18/2019
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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