The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Ultrasonic Processor Sp-900 And Fujifilm Ultrasonic Probe Pb2020-m2.
| Device ID | K214089 |
| 510k Number | K214089 |
| Device Name: | FUJIFILM Ultrasonic Processor SP-900 And FUJIFILM Ultrasonic Probe PB2020-M2 |
| 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 | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-28 |
| Decision Date | 2022-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410445886 | K214089 | 000 |
| 04547410342741 | K214089 | 000 |