The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Ultrasonic Endoscope.
| Device ID | K182825 |
| 510k Number | K182825 |
| Device Name: | FUJIFILM Ultrasonic Endoscope |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun, JP 258-8538 |
| Contact | Randy Vader |
| Correspondent | Jeffrey Wan FUJIFILM Medical Systems U.S.A., Inc. 419 West Ave Stamford, CT 06902 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-04 |
| Decision Date | 2019-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410330182 | K182825 | 000 |