The following data is part of a premarket notification filed by Bluepoint Medical Gmbh & Co. Kg with the FDA for 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.
| Device ID | K190824 |
| 510k 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 |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | Bluepoint Medical GmbH & Co. KG An Der Trave 15 Selmsdorf, DE 23923 |
| Contact | Bernd Lindner |
| Correspondent | Stephen Gorski Imagenix, Inc. S65 W35739 Piper Road Eagle, WI 53119 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-01 |
| Decision Date | 2019-12-18 |