The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Fujinon Epx-4440hd Digital Video Processor.
| Device ID | K102466 |
| 510k Number | K102466 |
| Device Name: | FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | FUJINON, INC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Contact | Curtis Raymond |
| Correspondent | Curtis Raymond FUJINON, INC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-30 |
| Decision Date | 2011-05-25 |
| Summary: | summary |