Device Type ID | 2596 |
Device Name | Cleaner, Air, Medical Recirculating |
Regulation Description | Medical Recirculating Air Cleaner. |
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 | 880.5045 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | FRF |
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 | 2596 |
Device | Cleaner, Air, Medical Recirculating |
Product Code | FRF |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Medical Recirculating Air Cleaner. |
CFR Regulation Number | 880.5045 [🔎] |