| Device Type ID | 2809 |
| Device Name | Unit, Isolation, Surgical |
| 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 Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.5070 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FRT |
| 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 | 2809 |
| Device | Unit, Isolation, Surgical |
| Product Code | FRT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Air-handling Apparatus For A Surgical Operating Room. |
| CFR Regulation Number | 878.5070 [🔎] |