EPX-4440HD DIGITAL VIDEO PROCESSOR— 510(k) K140149
Substantially EquivalentFujifilm Medical Systems U.S.A, Inc.
FDA 510(k) clearance K140149 for EPX-4440HD DIGITAL VIDEO PROCESSOR, Substantially Equivalent on 2014-08-22. Applicant: Fujifilm Medical Systems U.S.A, Inc..
Clearance details
- Applicant
- Fujifilm Medical Systems U.S.A, Inc.
- Product code
- Code PEA
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wayne, NJ, US
Adverse events under product code PEA
product code PEA- Malfunction
- 515
- Total
- 515
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.