The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm 600 Series Endoscope Eg-600wr V2.
| Device ID | K180341 |
| 510k Number | K180341 |
| Device Name: | FUJIFILM 600 Series Endoscope EG-600WR V2 |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun, JP 258-8538 |
| Contact | Randy Vader |
| Correspondent | Jeffrey Wan FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne, NJ 07470 |
| Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-07 |
| Decision Date | 2018-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410337402 | K180341 | 000 |