K241366 is an FDA 510(k) clearance for the QualityFlow O2 Series (QualityFLOW O2). This device is classified as a Valve, Non-rebreathing (Class II - Special Controls, product code CBP).
Submitted by Dehas Medical Systems GmbH (Luebeck, DE). The FDA issued a Cleared decision on October 29, 2024, 168 days after receiving the submission on May 14, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5870.
| 510(k) Number | K241366 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2024 |
| Decision Date | October 29, 2024 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBP - Valve, Non-rebreathing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5870 |