The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Olympus Small Intestinal Capsule Endoscope System.
| Device ID | K163069 |
| 510k Number | K163069 |
| Device Name: | OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM |
| Classification | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji, JP 182-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Daphney Germain-kolawole OLYMPUS CORPORATION OF THE AMERICAS 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | NEZ |
| CFR Regulation Number | 876.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-02 |
| Decision Date | 2017-01-19 |
| Summary: | summary |