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 | K072957 |
| 510k Number | K072957 |
| 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 | 2007-10-19 |
| Decision Date | 2008-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170343612 | K072957 | 000 |
| 04953170343582 | K072957 | 000 |
| 04953170340321 | K072957 | 000 |
| 04953170305023 | K072957 | 000 |
| 04953170305009 | K072957 | 000 |
| 04953170304903 | K072957 | 000 |
| 04953170287183 | K072957 | 000 |