EPX-4440FN Digital Video Processor with Light Source— 510(k) K180414
Substantially EquivalentFujifilm New Development U.S.A., Inc.
FDA 510(k) clearance K180414 for EPX-4440FN Digital Video Processor with Light Source, Substantially Equivalent on 2018-05-24. Applicant: Fujifilm New Development U.S.A., Inc..
Clearance details
- Applicant
- Fujifilm New Development U.S.A., Inc.
- Product code
- Code FET
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
Adverse events under product code FET
product code FET- Injury
- 313
- Malfunction
- 54,276
- Total
- 54,589
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.