The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Endoscope Reprocessor Oer-pro.
Device ID | K093106 |
510k Number | K093106 |
Device Name: | ENDOSCOPE REPROCESSOR OER-PRO |
Classification | Accessories, Cleaning, For Endoscope |
Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
Contact | Laura Storms-tyler |
Correspondent | Laura Storms-tyler OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY 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 | 2009-10-01 |
Decision Date | 2010-02-12 |
Summary: | summary |