| Device Type ID | 127 |
| Device Name | Hood, Oxygen, Infant |
| Regulation Description | Nonpowered Oxygen Tent. |
| 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 | 868.5700 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FOG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 127 |
| Device | Hood, Oxygen, Infant |
| Product Code | FOG |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Nonpowered Oxygen Tent. |
| CFR Regulation Number | 868.5700 [🔎] |