The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Fujifilm Ultrasonic Processor Sp-900 And Fujifilm Ultrasonic Probe Pb2020-m.
| Device ID | K171207 |
| 510k Number | K171207 |
| Device Name: | FUJIFILM Ultrasonic Processor SP-900 And FUJIFILM Ultrasonic Probe PB2020-M |
| Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
| Applicant | FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne, NJ 07470 |
| Contact | Jeffrey Wan |
| Correspondent | Jeffrey Wan FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne, NJ 07470 |
| 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 | 2017-04-25 |
| Decision Date | 2018-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410343052 | K171207 | 000 |
| 04547410342741 | K171207 | 000 |