DizzyDoctor System 1.0.0
FDA 510(k) K182214 · Dizzydoctor Systems, LLC
510(k) numberK182214
Submission
- Device name
- DizzyDoctor System 1.0.0
- Applicant
- Dizzydoctor Systems, LLC
San Diego, CA, US - Received
- August 15, 2018
- Decision date
- September 14, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
| K181025 | I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal…GWN · Special | Neuro Kinetics, Inc. | 07/24/2018SE |
Questions and answers
When was DizzyDoctor System 1.0.0 cleared by the FDA?
DizzyDoctor System 1.0.0 (K182214) received a 510(k) decision of Substantially Equivalent on September 14, 2018, 30 days after the submission was received.
What is the product code of K182214?
The FDA product code is GWN – Nystagmograph, a Class II (moderate risk) device regulated under 21 CFR 882.1460.