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 | K121959 |
| 510k Number | K121959 |
| Device Name: | EVIS EXERA III VIDEO SYSTEM |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY PO BOX 610 Center Vally, PA 18034 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY PO BOX 610 Center Vally, PA 18034 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-05 |
| Decision Date | 2013-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170342943 | K121959 | 000 |
| 04953170434778 | K121959 | 000 |
| 04953170434792 | K121959 | 000 |
| 04953170298622 | K121959 | 000 |
| 04953170298868 | K121959 | 000 |
| 04953170335174 | K121959 | 000 |
| 04953170335181 | K121959 | 000 |
| 04953170335198 | K121959 | 000 |
| 04953170342110 | K121959 | 000 |
| 04953170342134 | K121959 | 000 |
| 04953170342912 | K121959 | 000 |
| 04953170434754 | K121959 | 000 |