The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Endoscope Reprocessor Oer-mini.
| Device ID | K120357 |
| 510k Number | K120357 |
| Device Name: | ENDOSCOPE REPROCESSOR OER-MINI |
| Classification | Accessories, Cleaning, For Endoscope |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. 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 | 2012-02-06 |
| Decision Date | 2012-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170331633 | K120357 | 000 |
| 04953170331626 | K120357 | 000 |
| 04953170299353 | K120357 | 000 |
| 04953170234057 | K120357 | 000 |
| 04953170234040 | K120357 | 000 |
| 04953170312670 | K120357 | 000 |
| 04953170312663 | K120357 | 000 |
| 04953170331619 | K120357 | 000 |
| 04953170312656 | K120357 | 000 |