K250445
- 510(k) number
- K250445
- Device name
- Fast Warm - NX
- Applicant
- Fujifilm Irvine Scientific CA · US
- Product code
- MQL — Media, Reproductive
- Decision date
- 2025-09-12
- Date received
- 2025-02-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250445.pdf
Official FDA record: K250445
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.