The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Evis Exera Ii 180 System.
| Device ID | K062049 |
| 510k Number | K062049 |
| Device Name: | EVIS EXERA II 180 SYSTEM |
| Classification | Endoscope, Accessories, Narrow Band Spectrum |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | NWB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-20 |
| Decision Date | 2006-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170339523 | K062049 | 000 |
| 04953170304873 | K062049 | 000 |
| 04953170304842 | K062049 | 000 |
| 04953170294877 | K062049 | 000 |
| 04953170287619 | K062049 | 000 |
| 04953170287145 | K062049 | 000 |
| 04953170287091 | K062049 | 000 |
| 04953170275777 | K062049 | 000 |
| 04953170275753 | K062049 | 000 |
| 04953170228940 | K062049 | 000 |
| 04953170228933 | K062049 | 000 |
| 04953170228896 | K062049 | 000 |
| 04953170411298 | K062049 | 000 |
| 04953170411274 | K062049 | 000 |
| 04953170411250 | K062049 | 000 |
| 04953170411212 | K062049 | 000 |
| 04953170304880 | K062049 | 000 |
| 04953170304989 | K062049 | 000 |
| 04953170339455 | K062049 | 000 |
| 04953170339431 | K062049 | 000 |
| 04953170312779 | K062049 | 000 |
| 04953170310522 | K062049 | 000 |
| 04953170310508 | K062049 | 000 |
| 04953170310461 | K062049 | 000 |
| 04953170305535 | K062049 | 000 |
| 04953170305092 | K062049 | 000 |
| 04953170305085 | K062049 | 000 |
| 04953170305078 | K062049 | 000 |
| 04953170305061 | K062049 | 000 |
| 04953170305054 | K062049 | 000 |
| 04953170305047 | K062049 | 000 |
| 04953170305030 | K062049 | 000 |
| 04953170305016 | K062049 | 000 |
| 04953170411199 | K062049 | 000 |