The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Evis Exera Ii Duodenovideoscope Olympus Tjf Type Q180v.
| Device ID | K143153 |
| 510k Number | K143153 |
| Device Name: | EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V |
| Classification | Duodenoscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 2951 ISHIKAWA-CHO Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Sheri L Musgnung OLYMPUS CORPORATION OF THE AMERICAS 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | FDT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-03 |
| Decision Date | 2016-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170367311 | K143153 | 000 |
| 04953170339967 | K143153 | 000 |
| 04953170229503 | K143153 | 000 |