The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Vb Image Viewer.
Device ID | K080581 |
510k Number | K080581 |
Device Name: | VB IMAGE VIEWER |
Classification | System, X-ray, Tomography, Computed |
Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 |
Contact | Laura Storms-tyler |
Correspondent | Laura Storms-tyler OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-03-03 |
Decision Date | 2008-10-16 |
Summary: | summary |