K251872
- 510(k) number
- K251872
- Device name
- Biomoneta Avata Rx
- Applicant
- Biomoneta Research Private Limited IN
- Product code
- FRF — Cleaner, Air, Medical Recirculating
- Decision date
- 2025-11-14
- Date received
- 2025-06-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K251872
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.