The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Double Balloon Endoscope Ei580bt.
| Device ID | K183032 |
| 510k Number | K183032 |
| Device Name: | FUJIFILM Double Balloon Endoscope EI580BT |
| Classification | Enteroscope And Accessories |
| Applicant | FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun, JP 258-8538 |
| Contact | Randy Vader Vader |
| Correspondent | Jeffrey Wan FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Avenue Lexington, MA 02421 |
| Product Code | FDA |
| Subsequent Product Code | FDF |
| Subsequent Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-01 |
| Decision Date | 2019-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410384536 | K183032 | 000 |