| Device Type ID | 7 |
| Device Name | Mask, Gas, Anesthetic |
| Regulation Description | Anesthetic Gas 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) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 868.5550 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | BSJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 7 |
| Device | Mask, Gas, Anesthetic |
| Product Code | BSJ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Anesthetic Gas Mask. |
| CFR Regulation Number | 868.5550 [🔎] |
| Device Problems | |
|---|---|
Crack | 6 |
Break | 2 |
Detachment Of Device Component | 2 |
Inadequacy Of Device Shape And/or Size | 1 |
Hole In Material | 1 |
Inflation Problem | 1 |
Gas Leak | 1 |
| Total Device Problems | 14 |