The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Endoscope Models Eg-760r, Eg-760z, Ec-760r-v/l And Ec-760zp-v/l, And Fujifilm Water Tank Model Wt-603.
| Device ID | K172916 |
| 510k Number | K172916 |
| Device Name: | FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L And EC-760ZP-V/L, And FUJIFILM Water Tank Model WT-603 |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | Fujifilm Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun Kanagawa, 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-25 |
| Decision Date | 2018-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410366044 | K172916 | 000 |
| 14547410358695 | K172916 | 000 |
| 14547410358688 | K172916 | 000 |
| 14547410358671 | K172916 | 000 |
| 04547410358667 | K172916 | 000 |