The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Balloon Bs-3.
| Device ID | K213195 |
| 510k Number | K213195 |
| Device Name: | Balloon BS-3 |
| Classification | Enteroscope And Accessories |
| Applicant | FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun, JP 258-8538 |
| Contact | Randy Vader |
| Correspondent | Jeffrey Wan FUJIFILM Healthcare Americas Corporation 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 | 2021-09-29 |
| Decision Date | 2021-10-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410463439 | K213195 | 000 |