The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Fujifilm Video Colonoscope Model Ec-600wl V2.
| Device ID | K160196 |
| 510k Number | K160196 |
| Device Name: | Fujifilm Video Colonoscope Model EC-600WL V2 |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne, NJ 07470 |
| Contact | Shraddha More |
| Correspondent | John J. Smith Hogan Lovells US LLP 555 Thirteenth St. NW Washington, DC 20004 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-27 |
| Decision Date | 2016-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410337396 | K160196 | 000 |