| Device Type ID | 2543 |
| Device Name | Cabinet, Ethylene-oxide Gas Aerator |
| Regulation Description | Ethylene Oxide Gas Aerator Cabinet. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Infection Control Devices Branch (INCB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.6100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FLI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 2543 |
| Device | Cabinet, Ethylene-oxide Gas Aerator |
| Product Code | FLI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ethylene Oxide Gas Aerator Cabinet. |
| CFR Regulation Number | 880.6100 [🔎] |