The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Evis Exeraii 180 System.
| Device ID | K100584 |
| 510k Number | K100584 |
| Device Name: | EVIS EXERAII 180 SYSTEM |
| Classification | Endoscope, Accessories, Narrow Band Spectrum |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION REGULATORY AFFAIRS & QUALITY 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Contact | Stacy A Kluesner |
| Correspondent | Stacy A Kluesner OLYMPUS MEDICAL SYSTEMS CORPORATION REGULATORY AFFAIRS & QUALITY 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Product Code | NWB |
| Subsequent Product Code | FDF |
| Subsequent Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-02 |
| Decision Date | 2010-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170339905 | K100584 | 000 |
| 04953170307522 | K100584 | 000 |
| 04953170307515 | K100584 | 000 |
| 04953170307508 | K100584 | 000 |
| 04953170275425 | K100584 | 000 |
| 04953170237300 | K100584 | 000 |
| 04953170237294 | K100584 | 000 |
| 04953170237287 | K100584 | 000 |
| 04953170202544 | K100584 | 000 |
| 04953170202506 | K100584 | 000 |
| 04953170202445 | K100584 | 000 |
| 04953170202339 | K100584 | 000 |
| 04953170202315 | K100584 | 000 |
| 04953170202285 | K100584 | 000 |
| 04953170202278 | K100584 | 000 |
| 04953170202261 | K100584 | 000 |
| 04953170307690 | K100584 | 000 |
| 04953170307706 | K100584 | 000 |
| 04953170339899 | K100584 | 000 |
| 04953170339882 | K100584 | 000 |
| 04953170339875 | K100584 | 000 |
| 04953170339776 | K100584 | 000 |
| 04953170339769 | K100584 | 000 |
| 04953170339615 | K100584 | 000 |
| 04953170339608 | K100584 | 000 |
| 04953170339592 | K100584 | 000 |
| 04953170339585 | K100584 | 000 |
| 04953170339189 | K100584 | 000 |
| 04953170339172 | K100584 | 000 |
| 04953170339097 | K100584 | 000 |
| 04953170339080 | K100584 | 000 |
| 04953170307720 | K100584 | 000 |
| 04953170307713 | K100584 | 000 |
| 04953170202247 | K100584 | 000 |