The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Endoscope Reprocessor Oer-elite.
| Device ID | K190969 |
| 510k Number | K190969 |
| Device Name: | ENDOSCOPE REPROCESSOR OER-Elite |
| Classification | Accessories, Cleaning, For Endoscope |
| 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 | FEB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-12 |
| Decision Date | 2019-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170404047 | K190969 | 000 |
| 04953170404191 | K190969 | 000 |
| 04953170404054 | K190969 | 000 |
| 04953170404061 | K190969 | 000 |
| 04953170404078 | K190969 | 000 |
| 04953170404085 | K190969 | 000 |
| 04953170404092 | K190969 | 000 |
| 04953170404108 | K190969 | 000 |
| 04953170404115 | K190969 | 000 |
| 04953170404122 | K190969 | 000 |
| 04953170404139 | K190969 | 000 |
| 04953170404146 | K190969 | 000 |
| 04953170404153 | K190969 | 000 |
| 04953170404160 | K190969 | 000 |
| 04953170404184 | K190969 | 000 |
| 04953170404207 | K190969 | 000 |
| 04953170401473 | K190969 | 000 |