The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Evis Exera Iii Gastrointestinal Videoscope Olympus Gixp190n.
| Device ID | K123317 |
| 510k Number | K123317 |
| Device Name: | EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-25 |
| Decision Date | 2012-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170334146 | K123317 | 000 |
| 04953170305313 | K123317 | 000 |
| 04953170436772 | K123317 | 000 |