FRF
- Product code
- FRF
- Device name
- Cleaner, Air, Medical Recirculating
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5045
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 53
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251872 | 2025-11-14 | Biomoneta Research Private Limited | Biomoneta Avata Rx | — |
| K242102 | 2024-11-19 | Cerrozone, LLC | CerroZone Mini | |
| K240696 | 2024-06-14 | Suzhou Beiang Smart Technology Co., Lt | Airdog X8 Air Purifier (KJ800F-X8) | FDA |
| K223835 | 2023-09-18 | Medify Air, LLC | MA-40, MA-112 | — |
Official FDA classification page: FRF
Classification and pathway per current FDA publications. Data from openFDA (CC0).