The following data is part of a premarket notification filed by Fujifilm New Development U.s.a., Inc. with the FDA for Epx-4440fn Digital Video Processor With Light Source.
| Device ID | K180414 |
| 510k Number | K180414 |
| Device Name: | EPX-4440FN Digital Video Processor With Light Source |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | FUJIFILM New Development U.S.A., Inc. 318 Bear Hill Road Waltham, MA 02451 |
| Contact | Stephen Mariano |
| Correspondent | Maureen O'connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 |
| Product Code | FET |
| Subsequent Product Code | GCT |
| Subsequent Product Code | PEA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-15 |
| Decision Date | 2018-05-24 |
| Summary: | summary |