| Device Type ID | 5570 |
| Device Name | Apparatus, Air Handling, Enclosure |
| Regulation Description | Air-handling Apparatus For A Surgical Operating Room. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.5070 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FZI |
| 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 | 5570 |
| Device | Apparatus, Air Handling, Enclosure |
| Product Code | FZI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Air-handling Apparatus For A Surgical Operating Room. |
| CFR Regulation Number | 878.5070 [🔎] |