The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Endoscope Model Ec-760s-v/l.
| Device ID | K190649 |
| 510k Number | K190649 |
| Device Name: | FUJIFILM Endoscope Model EC-760S-V/L |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun, JP 258-8538 |
| Contact | Randy Vader |
| Correspondent | Liza Dejesa-jamanila FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 Lexington, MA 02421 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-13 |
| Decision Date | 2019-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14547410397649 | K190649 | 000 |