K232642
- 510(k) number
- K232642
- Device name
- AirKEE T900
- Applicant
- Healkee Medical Pte, Ltd. SG
- Product code
- FRA — Purifier, Air, Ultraviolet, Medical
- Decision date
- 2024-05-23
- Date received
- 2023-08-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K232642.pdf
Official FDA record: K232642
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.