The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Evis Exera Iii Video System.
| Device ID | K131780 |
| 510k Number | K131780 |
| Device Name: | EVIS EXERA III VIDEO SYSTEM |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Contact | Daphney Germain-kolawole |
| Correspondent | Daphney Germain-kolawole OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Product Code | FDF |
| Subsequent Product Code | FDS |
| Subsequent Product Code | NWB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-17 |
| Decision Date | 2013-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170298868 | K131780 | 000 |
| 04953170305238 | K131780 | 000 |
| 04953170305214 | K131780 | 000 |
| 04953170305191 | K131780 | 000 |
| 04953170305177 | K131780 | 000 |
| 04953170305153 | K131780 | 000 |
| 04953170305115 | K131780 | 000 |
| 04953170304972 | K131780 | 000 |
| 04953170304835 | K131780 | 000 |
| 04953170305252 | K131780 | 000 |
| 04953170436574 | K131780 | 000 |
| 04953170298622 | K131780 | 000 |
| 04953170438097 | K131780 | 000 |
| 04953170436710 | K131780 | 000 |
| 04953170436697 | K131780 | 000 |
| 04953170436673 | K131780 | 000 |
| 04953170436659 | K131780 | 000 |
| 04953170436635 | K131780 | 000 |
| 04953170436611 | K131780 | 000 |
| 04953170071713 | K131780 | 000 |