Fast Warm - NX— 510(k) K250445
Substantially EquivalentFujifilm Irvine Scientific
FDA 510(k) clearance K250445 for Fast Warm - NX, Substantially Equivalent on 2025-09-12. Applicant: Fujifilm Irvine Scientific. Device class: 2.
Clearance details
- Applicant
- Fujifilm Irvine Scientific
- Product code
- Code MQL
- Device class
- Class 2
- Regulation
- 21 CFR 884.6180
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
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More clearances from Fujifilm Irvine Scientific
view allData sourced from openFDA. This site is unofficial and independent of the FDA.