The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Evis Exera Iii Duodenovideoscope Olympus Tjf-q190v.
| Device ID | K220587 |
| 510k Number | K220587 |
| Device Name: | Evis Exera III Duodenovideoscope Olympus TJF-Q190V |
| Classification | Duodenoscope And Accessories, Flexible/rigid |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshio Nakamura |
| Correspondent | Wendy Perreault Olympus Corporation Of The Americas 3500 Corporate Parkway, P.O. Box 610 Center Valley, PA 18034 -0610 |
| Product Code | FDT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-01 |
| Decision Date | 2022-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170452024 | K220587 | 000 |
| 14953170441278 | K220587 | 000 |