Definition: The Sytem Is Intended To Control The Surgical Environment To Prevent Bacterial Contamination During Surgical Procedures.
| Device Type ID | 2839 |
| Device Name | Air Filter Portable Apparatus |
| Physical State | A Reusable Mobile HEPA Air Filtration Unit With A Hose Connecting To A Disposable Air Delivery Unit To Be Place At The Surgical Site. |
| Technical Method | The System Uses An Air Supply Hose Connected To Nozzle Design That Is To Be Mounted, Or Applied To The Incision Drape In Close Proximity To The Surgical Site To Provide Direct Air Flow Blowing Over The Surgical Incision Site That Helps Reduce The Lev |
| Target Area | Surgical Site. |
| Regulation Description | Air-handling Apparatus For A Surgical Operating Room. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.5070 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ORC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2839 |
| Device | Air Filter Portable Apparatus |
| Product Code | ORC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Air-handling Apparatus For A Surgical Operating Room. |
| CFR Regulation Number | 878.5070 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
TOUL MEDITECH AB | ||
SUBSTANTIALLY EQUIVALENT | 2 | |