The following data is part of a premarket notification filed by Fujifilm Corporaton with the FDA for Processor Vp-7000, Light Source Bl-7000x, Image Processing Unit Ex-0.
| Device ID | K203717 |
| 510k Number | K203717 |
| Device Name: | Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | FUJIFILM Corporaton 798 Miyanodai Kaisei-Machi Ashigarakami-gun, JP 258-8538 |
| Contact | Randy Vader |
| Correspondent | Jeffrey Wan Fujifilm Medical Systems U.S.A, Inc. 81 Hartwell Avenue, Suite 300 Lexington, MA 02421 |
| Product Code | GCJ |
| Subsequent Product Code | FET |
| Subsequent Product Code | MUD |
| 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 | 2020-12-21 |
| Decision Date | 2021-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410446104 | K203717 | 000 |
| 04547410446081 | K203717 | 000 |
| 04547410337419 | K203717 | 000 |