510(k) K190824 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
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, Selmsdorf, DE |
| Decision | Substantially Equivalent, Dec 18, 2019 |
| Received | Apr 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190824
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.