VisualEyes
FDA 510(k) K200534 · Interacoustics A/S
510(k) numberK200534
Submission
- Device name
- VisualEyes
- 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
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| K260566 | SMARTVERTIGO Vestibular Assessment SystemGWN · Traditional | VertigoDx, Inc. | 07/30/2026SE |
| K243709 | NeuroEars-AnnaGWN · Traditional | Neuroears, Inc. | 08/25/2025SE |
| K242198 | ICS Dizcovery (1091)GWN · Traditional | Natus Medical Denmark Aps | 02/14/2025SE |
| K242726 | Synapsys VHITGWN · Traditional | Inventis S.R.L. | 01/03/2025SE |
| K223047 | NeuroSwift ProGWN · Traditional | Neurobit Technologies Co., Ltd. | 06/29/2023SE |
| K203082 | Insight Infrared Video GogglesGWN · Traditional | Vestibular First | 11/12/2020SE |
| K192186 | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal…GWN · Traditional | Neurolign USA, LLC | 11/29/2019SE |
| K181771 | RightEye Vision SystemGWN · Traditional | Righteye, LLC | 09/28/2018SE |
| K182214 | DizzyDoctor System 1.0.0GWN · Traditional | Dizzydoctor Systems, LLC | 09/14/2018SE |
| K181025 | I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal…GWN · Special | Neuro Kinetics, Inc. | 07/24/2018SE |
More from Neuro Kinetics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K200529 | OrionLXV · 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 VisualEyes cleared by the FDA?
VisualEyes (K200534) 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 K200534?
The FDA product code is GWN – Nystagmograph, a Class II (moderate risk) device regulated under 21 CFR 882.1460.