K250434
- 510(k) number
- K250434
- Device name
- trophon2
- Applicant
- Nanosonics AU
- Product code
- OUJ — High Level Disinfection Reprocessing Instrument For
- Decision date
- 2025-08-05
- Date received
- 2025-02-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250434.pdf
Official FDA record: K250434
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.