FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
VisualEyes
K Number: K200534
·
Decision Aug 12, 2020
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
58
Applicant Total
17
Review Days
163
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Basic Information
- Device Name
- VisualEyes
- K Number
- K200534
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1460
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Interacoustics A/S
- Date Received
- March 2, 2020
- Decision Date
- August 12, 2020
- Product Code
- GWN
- Advisory Committee
- Neurology
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GWN | Nystagmograph | FDA class 2 | Neurology |
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Other Clearances by Interacoustics A/S
| K Number | Device Name | ||
|---|---|---|---|
| K200529 | Orion | Aug 12, 2020 | Substantially Equivalent |
| K192652 | TRV | May 27, 2020 | Substantially Equivalent |
| K191372 | Lyra | Jul 15, 2019 | Substantially Equivalent |
| K173567 | Sera | Feb 14, 2018 | Substantially Equivalent |
| K163149 | VisualEyes | Apr 26, 2017 | Substantially Equivalent |
| K162037 | Eclipse with VEMP | Mar 23, 2017 | Substantially Equivalent |
| K152112 | VisualEyes | Dec 29, 2015 | Substantially Equivalent |
| K151616 | AT235 | Jul 15, 2015 | Substantially Equivalent |
| K131681 | EYESEECAM VHIT | Sep 6, 2013 | Substantially Equivalent |
| K130795 | TITAN | Jun 20, 2013 | Substantially Equivalent |