The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Ep-6000 Video Processor.
| Device ID | K192286 |
| 510k Number | K192286 |
| Device Name: | FUJIFILM EP-6000 Video Processor |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun, JP 258-8538 |
| Contact | Randy Vader |
| Correspondent | Candace Alva FujiFilm Medical Systems U.S.A., Inc. 81 Hartwell Avenue Lexington, MA 02421 |
| Product Code | FET |
| Subsequent Product Code | EOQ |
| Subsequent Product Code | NTN |
| Subsequent Product Code | NWB |
| Subsequent Product Code | PEA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-22 |
| Decision Date | 2020-05-01 |