Focus Vng/Eng Type 1068
FDA 510(k) K061791 · Gn Otometrics A/S
510(k) numberK061791
Submission
- Device name
- Focus Vng/Eng Type 1068
- Applicant
- Gn Otometrics A/S
Schaumburg, IL, US - Received
- June 26, 2006
- Decision date
- July 11, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K200534 | VisualEyesGWN · Traditional | Interacoustics A/S | 08/12/2020SE |
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| 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
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|---|---|---|
| K143670 | Ics Chartr Ep 200 with VempGWJ · Traditional | 10/23/2015SE |
| K110286 | GN Otometrics Type 1053 FreefitETW · Traditional | 04/28/2011SE |
| K083399 | Ics Chartr Ep 200GWJ · Traditional | 02/20/2009SE |
| K061104 | Speechlink 100 Type 1053ETW · Traditional | 05/03/2006SE |
| K033645 | Otoflex 100 Tye 1012ETY · Traditional | 03/31/2004SE |
Questions and answers
When was Focus Vng/Eng Type 1068 cleared by the FDA?
Focus Vng/Eng Type 1068 (K061791) received a 510(k) decision of Substantially Equivalent on July 11, 2006, 15 days after the submission was received.
What is the product code of K061791?
The FDA product code is GWN – Nystagmograph, a Class II (moderate risk) device regulated under 21 CFR 882.1460.