| Device Type ID | 48 |
| Device Name | Mask, Oxygen, Low Concentration, Venturi |
| Regulation Description | Venturi Mask. |
| 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) Exempt |
| CFR Regulation Number | 868.5600 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | BYF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 48 |
| Device | Mask, Oxygen, Low Concentration, Venturi |
| Product Code | BYF |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Venturi Mask. |
| CFR Regulation Number | 868.5600 [🔎] |
| Device Problems | |
|---|---|
Inadequacy Of Device Shape And/or Size | 2 |
Inaccurate Flow Rate | 2 |
Connection Problem | 1 |
Fitting Problem | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Air Leak | 1 |
Device Markings / Labelling Problem | 1 |
| Total Device Problems | 9 |