The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Epx-4440hd Digital Video Processor.
| Device ID | K140149 |
| 510k Number | K140149 |
| Device Name: | EPX-4440HD DIGITAL VIDEO PROCESSOR |
| Classification | Endoscope, Accessories, Image Post-processing For Color Enhancement |
| Applicant | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 10 HIGH POINT DR Wayne, NJ 07470 |
| Contact | Mary K Moore |
| Correspondent | Mary K Moore FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 10 HIGH POINT DR Wayne, NJ 07470 |
| Product Code | PEA |
| Subsequent Product Code | FET |
| Subsequent Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-22 |
| Decision Date | 2014-08-22 |
| Summary: | summary |