K232933
- 510(k) number
- K232933
- Device name
- AirKEE P900
- Applicant
- Healkee Medical Pte, Ltd. SG
- Product code
- FRA — Purifier, Air, Ultraviolet, Medical
- Decision date
- 2024-05-16
- Date received
- 2023-09-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K232933.pdf
Official FDA record: K232933
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.