Bluepoint Medical GmbH & Co. KG · Class II · Cleared Dec 18, 2019
| 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 |
| Product code | CCK |
| Device class | Class II |
| Decision date | Dec 18, 2019 |
| Decision | Substantially Equivalent |
| Regulation | 868.1400 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov