The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Endoscope Reprocessor Oer-pro Model Oer-pro.
| Device ID | K103264 |
| 510k Number | K103264 |
| Device Name: | ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO |
| Classification | Accessories, Cleaning, For Endoscope |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 |
| Contact | Stacy Abbatiell Kluesner, Ms, Rac |
| Correspondent | Stacy Abbatiell Kluesner, Ms, Rac OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 |
| Product Code | FEB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-04 |
| Decision Date | 2011-02-23 |
| Summary: | summary |