ICS Impulse
FDA 510(k) K151504 · Gn Otometrics
510(k) numberK151504
Submission
- Device name
- ICS Impulse
- Applicant
- Gn Otometrics
Taastrup, DK - Received
- June 4, 2015
- Decision date
- November 16, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GWN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K200534 | VisualEyesGWN · Traditional | Interacoustics A/S | 08/12/2020SE |
| 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 |
More from Dizzydoctor Systems, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K161707 | Madsen ZodiacETY · Special | 09/01/2016SE |
| K132957 | Madsen Accuscreen Type 1077GWJ · Traditional | 02/27/2014SE |
| K122550 | Ics ImpulseGWN · Traditional | 02/01/2013SE |
| K122028 | Aurical HitETW · Traditional | 10/23/2012SE |
| K122067 | Type 1077 AccuscreenGWJ · Traditional | 09/27/2012SE |
| K092373 | Ics Chartr Ep 200GWJ · Special | 09/03/2009SE |
| K081234 | GN Otometrics Insert EarphonesEWO · Traditional | 07/14/2008SE |
Questions and answers
When was ICS Impulse cleared by the FDA?
ICS Impulse (K151504) received a 510(k) decision of Substantially Equivalent on November 16, 2015, 165 days after the submission was received.
What is the product code of K151504?
The FDA product code is GWN – Nystagmograph, a Class II (moderate risk) device regulated under 21 CFR 882.1460.