The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Double Balloon Endoscopes En-580t, Ec-450bi5, En-450p5/20, And En-450t5.
| Device ID | K183683 |
| 510k Number | K183683 |
| Device Name: | FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, And EN-450T5 |
| Classification | Enteroscope And Accessories |
| 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 81 Hartwell Avenue, Suite 300 Lexington, MA 02421 |
| Product Code | FDA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-28 |
| Decision Date | 2019-02-27 |
| Summary: | summary |