510(k) K180414
K180414 is an FDA 510(k) premarket notification submitted by Fujifilm New Development U.S.A., Inc. for the device "EPX-4440FN Digital Video Processor with Light Source". The FDA issued a decision of Substantially Equivalent on May 24, 2018. The device falls under product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Fujifilm New Development U.S.A., Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 2018
- Date Received
- Feb 15, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
- 510(k)
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.