The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Fujifilm Endoscope Models Ec-600hl And Ec-600ls.
| Device ID | K162622 |
| 510k Number | K162622 |
| Device Name: | Fujifilm Endoscope Models EC-600HL And EC-600LS |
| 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 | Shraddha More FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne, NJ 07470 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-20 |
| Decision Date | 2016-10-18 |
| Summary: | summary |