The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Ultrasonic Endoscope Eg-740ut.
| Device ID | K221238 |
| 510k Number | K221238 |
| Device Name: | FUJIFILM Ultrasonic Endoscope EG-740UT |
| Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
| Applicant | FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, JP 258-8538 |
| Contact | Randy Vader |
| Correspondent | Kotei Aoki FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 Lexington, MA 02421 |
| Product Code | ODG |
| Subsequent Product Code | FDS |
| Subsequent Product Code | ITX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-29 |
| Decision Date | 2022-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14547410446149 | K221238 | 000 |
| 04547410446128 | K221238 | 000 |
| 14547410416173 | K221238 | 000 |