| Device Type ID | 2594 |
| Device Name | Purifier, Air, Ultraviolet, Medical |
| Regulation Description | Medical Ultraviolet Air Purifier. |
| 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 | 880.6500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FRA |
| 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 | 2594 |
| Device | Purifier, Air, Ultraviolet, Medical |
| Product Code | FRA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Medical Ultraviolet Air Purifier. |
| CFR Regulation Number | 880.6500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
HGI INDUSTIRES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Tube | 1 |
Material Separation | 1 |
| Total Device Problems | 2 |