Orion
FDA 510(k) K200529 · Interacoustics A/S
510(k) numberK200529
Submission
- Device name
- Orion
- Applicant
- Interacoustics A/S
Middelfart, DK - Received
- March 2, 2020
- Decision date
- August 12, 2020
- 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 |
| 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 |
| K071973 | Epley OmniaxLXV · Traditional | Vesticon | 06/20/2008SE |
More from Vesticon
| 510(k) | Device | Decision |
|---|---|---|
| K200534 | VisualEyesGWN · Traditional | 08/12/2020SE |
| K192652 | TRVLXV · Traditional | 05/27/2020SE |
| K191372 | LyraEWO · Traditional | 07/15/2019SE |
| K173567 | SeraEWO · Traditional | 02/14/2018SE |
| K163149 | VisualEyesGWN · Traditional | 04/26/2017SE |
| K162037 | Eclipse with VEMPGWJ · Traditional | 03/23/2017SE |
| K152112 | VisualEyesGWN · Traditional | 12/29/2015SE |
| K151616 | AT235ETY · Special | 07/15/2015SE |
| K131681 | Eyeseecam VhitGWN · Traditional | 09/06/2013SE |
| K130795 | TitanEWO · Traditional | 06/20/2013SE |
Questions and answers
When was Orion cleared by the FDA?
Orion (K200529) received a 510(k) decision of Substantially Equivalent on August 12, 2020, 163 days after the submission was received.
What is the product code of K200529?
The FDA product code is LXV – Apparatus, Vestibular Analysis, a Unclassified device.