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 | K201920 |
| 510k Number | K201920 |
| 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 | Lisa Boyle 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-10 |
| Decision Date | 2020-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170404191 | K201920 | 000 |
| 04953170069475 | K201920 | 000 |
| 04953170069482 | K201920 | 000 |
| 04953170069611 | K201920 | 000 |
| 04953170069628 | K201920 | 000 |
| 04953170438271 | K201920 | 000 |
| 04953170438288 | K201920 | 000 |
| 04953170438295 | K201920 | 000 |
| 04953170438318 | K201920 | 000 |
| 04953170438325 | K201920 | 000 |
| 04953170404047 | K201920 | 000 |
| 04953170069468 | K201920 | 000 |