Definition: Intended To Deliver High Flow And/or High Velocity Oxygen With Humidification.
| Device Type ID | 204 |
| Device Name | High Flow/high Velocity Humidified Oxygen Delivery Device |
| Physical State | This Device Can Have A Means Of Delivering Humidified High Flow And/or High Velocity Oxygen That May Include High Flow Nasal Cannula. The Device May Have A Mechanical Means Of Blending Oxygen To The Appropriate Concentration. |
| Technical Method | The Device Introduces Humidified High Flow And/or High Velocity Oxygen Into The Respiratory System. |
| Target Area | Lung, Airways, Nasal Passages |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Respiratory Devices Branch (RPDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.5454 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QAV |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 204 |
| Device | High Flow/high Velocity Humidified Oxygen Delivery Device |
| Product Code | QAV |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 868.5454 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
VAPOTHERM | ||
GRANTED | 1 | |
VAPOTHERM, INC. | ||
GRANTED | 1 | |