The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Evis Exera 180 System.
| Device ID | K061313 |
| 510k Number | K061313 |
| Device Name: | EVIS EXERA 180 SYSTEM |
| Classification | Bronchoscope (flexible Or Rigid) |
| 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 | EOQ |
| Subsequent Product Code | EOB |
| Subsequent Product Code | NWB |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-10 |
| Decision Date | 2006-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170339509 | K061313 | 000 |
| 04953170288937 | K061313 | 000 |
| 04953170233012 | K061313 | 000 |
| 04953170063800 | K061313 | 000 |
| 14953170154291 | K061313 | 000 |
| 14953170152433 | K061313 | 000 |
| 14953170152426 | K061313 | 000 |
| 04953170411472 | K061313 | 000 |
| 04953170411441 | K061313 | 000 |
| 04953170411403 | K061313 | 000 |
| 04953170411366 | K061313 | 000 |
| 04953170411342 | K061313 | 000 |
| 04953170411083 | K061313 | 000 |
| 04953170216961 | K061313 | 000 |
| 04953170215544 | K061313 | 000 |
| 04953170288975 | K061313 | 000 |
| 04953170289002 | K061313 | 000 |
| 04953170339349 | K061313 | 000 |
| 04953170339325 | K061313 | 000 |
| 04953170339301 | K061313 | 000 |
| 04953170339288 | K061313 | 000 |
| 04953170317965 | K061313 | 000 |
| 04953170310447 | K061313 | 000 |
| 04953170310416 | K061313 | 000 |
| 04953170308222 | K061313 | 000 |
| 04953170308215 | K061313 | 000 |
| 04953170308208 | K061313 | 000 |
| 04953170308192 | K061313 | 000 |
| 04953170291098 | K061313 | 000 |
| 04953170291050 | K061313 | 000 |
| 04953170291029 | K061313 | 000 |
| 04953170215513 | K061313 | 000 |