The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Endoscope Models Eg-760ct, Ec-760p-v/l And Ec-740t/l.
| Device ID | K183572 |
| 510k Number | K183572 |
| Device Name: | FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L And EC-740T/L |
| 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. 419 West Ave Stamford, CT 06902 |
| Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-21 |
| Decision Date | 2019-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14547410368878 | K183572 | 000 |
| 04547410368864 | K183572 | 000 |
| 14547410368854 | K183572 | 000 |