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 | K183053 |
| 510k Number | K183053 |
| Device Name: | Olympus Small Intestinal Capsule Endoscope System |
| Classification | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| 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 | 2018-11-02 |
| Decision Date | 2019-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170328244 | K183053 | 000 |
| 04953170214332 | K183053 | 000 |
| 04953170328268 | K183053 | 000 |
| 04953170328299 | K183053 | 000 |
| 04953170328312 | K183053 | 000 |
| 04953170328350 | K183053 | 000 |
| 04953170328381 | K183053 | 000 |
| 04953170333316 | K183053 | 000 |
| 04953170333330 | K183053 | 000 |
| 14953170373760 | K183053 | 000 |
| 14953170373807 | K183053 | 000 |
| 14953170373845 | K183053 | 000 |
| 04953170402173 | K183053 | 000 |
| 04953170214325 | K183053 | 000 |