The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Processor Vp-7000, Light Source Bl-7000.
| Device ID | K163675 |
| 510k Number | K163675 |
| Device Name: | Processor VP-7000, Light Source BL-7000 |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | FUJIFILM Medical System U.S.A., Inc. 10 High Point Drive Wayne, NJ 07470 |
| Contact | Shraddha S More |
| Correspondent | Shraddha S More FUJIFILM Medical System U.S.A., Inc. 10 High Point Drive Wayne, NJ 07470 |
| Product Code | FET |
| 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 | 2016-12-27 |
| Decision Date | 2017-04-25 |
| Summary: | summary |