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 | K202661 |
| 510k Number | K202661 |
| 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 | Toshiyuki Nakajima |
| Correspondent | Sheri L. Musgnung Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034 -0610 |
| Product Code | FDT |
| Subsequent Product Code | FEB |
| Subsequent Product Code | NWB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-14 |
| Decision Date | 2020-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170409820 | K202661 | 000 |
| 04953170438349 | K202661 | 000 |