510(k) K190824

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 by Bluepoint Medical GmbH & Co. KG — Product Code CCK

K190824 is an FDA 510(k) premarket notification submitted by Bluepoint Medical GmbH & Co. KG for the device "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". The FDA issued a decision of Substantially Equivalent on Dec 18, 2019. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Bluepoint Medical GmbH & Co. KG has 1 other 510(k) clearance on record.