Epley Omniax
FDA 510(k) K071973 · Vesticon
510(k) numberK071973
Submission
- Device name
- Epley Omniax
- Applicant
- Vesticon
Portland, OR, US - Received
- July 17, 2007
- Decision date
- June 20, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LXV – Apparatus, Vestibular Analysis
- Device class
- Unclassified
Other 510(k)s with product code LXV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220231 | GyroStimLXV · Traditional | Ultrathera Technologies, Inc. | 04/27/2022SE |
| K200529 | OrionLXV · Traditional | Interacoustics A/S | 08/12/2020SE |
| K192652 | TRVLXV · Traditional | Interacoustics A/S | 05/27/2020SE |
| K183661 | ClearEdge Balance SystemLXV · Traditional | Quadrant Biosciences | 10/22/2019SE |
| K190735 | EQ BalanceLXV · Traditional | Upright Science, Inc. | 08/16/2019SE |
| K173669 | K-D BalanceLXV · Traditional | King-Devick Technologies, Inc. | 04/02/2018SE |
| K121590 | Vestibular Analysis ApparatusLXV · Traditional | Capacity Sports, LLC | 09/20/2012SE |
| K102364 | Nydiag 200LXV · Traditional | Interacoustics A/S | 12/23/2010SE |
| K082634 | Vertigone BPPV GoggleLXV · Traditional | Vertigone, Inc. | 04/07/2009SE |
| K081602 | DizzyfixLXV · Traditional | Clearwater Clinical Limited | 09/19/2008SE |
Questions and answers
When was Epley Omniax cleared by the FDA?
Epley Omniax (K071973) received a 510(k) decision of Substantially Equivalent on June 20, 2008, 339 days after the submission was received.
What is the product code of K071973?
The FDA product code is LXV – Apparatus, Vestibular Analysis, a Unclassified device.