K252128
- 510(k) number
- K252128
- Device name
- Zener® (model ZEN-001-B1)
- Applicant
- Uvx, Inc. CA
- Product code
- FRA — Purifier, Air, Ultraviolet, Medical
- Decision date
- 2025-09-15
- Date received
- 2025-07-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K252128.pdf
Official FDA record: K252128
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.