The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Visera Elite Ii Video System Center.
| Device ID | K202646 |
| 510k Number | K202646 |
| Device Name: | Visera Elite II Video System Center |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Anne-marie Keefe Olympus Surgical Technologies Of America 118 Turnpike Road, Suite 120 Southborough, MA 01772 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-11 |
| Decision Date | 2020-10-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170386077 | K202646 | 000 |
| 04953170305047 | K202646 | 000 |
| 04953170304996 | K202646 | 000 |
| 04953170148545 | K202646 | 000 |