CBP
- Product code
- CBP
- Device name
- Valve, Non-Rebreathing
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5870
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 103
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K241366 | 2024-10-29 | Dehas Medical Systems GmbH | QualityFlow O2 Series (QualityFLOW O2); QualityFlow summary |
| K234053 | 2024-08-09 | Fisher & Paykel Healthcare, Ltd. | F&P Optiflow Flow Diverter summary |
Official FDA classification page: CBP
Classification and pathway per current FDA publications. Data from openFDA (CC0).