K232645
- 510(k) number
- K232645
- Device name
- Airgle Room Air Purifier
- Applicant
- Airgle Corporation NY · US
- Product code
- FRA — Purifier, Air, Ultraviolet, Medical
- Decision date
- 2024-02-16
- Date received
- 2023-08-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232645.pdf
Official FDA record: K232645
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.