The following data is part of a premarket notification filed by Vesticon with the FDA for Epley Omniax.
| Device ID | K071973 |
| 510k Number | K071973 |
| Device Name: | EPLEY OMNIAX |
| Classification | Apparatus, Vestibular Analysis |
| Applicant | VESTICON 2203 NE OREGON STREET Portland, OR 97232 |
| Contact | Cathryn Epley |
| Correspondent | Cathryn Epley VESTICON 2203 NE OREGON STREET Portland, OR 97232 |
| Product Code | LXV |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-17 |
| Decision Date | 2008-06-20 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EPLEY OMNIAX 77032210 3521152 Dead/Cancelled |
EPLEY RESEARCH, LLC 2006-10-30 |