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 |