The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Epx-4440hd And Epx-4400hd With Fice.
| Device ID | K150221 |
| 510k Number | K150221 |
| Device Name: | EPX-4440HD And EPX-4400HD With FICE |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 10 HIGH POINT DRIVE Wayne, NJ 07470 |
| Contact | Mary Moore |
| Correspondent | Mary Moore FUJIFILM MEDICAL SYSTEM U.S.A., INC. 10 HIGH POINT DRIVE Wayne, NJ 07470 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-30 |
| Decision Date | 2015-10-01 |
| Summary: | summary |