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 |