510(k) K181771
K181771 is an FDA 510(k) premarket notification submitted by Righteye, LLC for the device "RightEye Vision System". The FDA issued a decision of Substantially Equivalent on September 28, 2018. The device falls under product code GWN (Nystagmograph), a Class II device regulated under 21 CFR 882.1460.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 2018
- Date Received
- July 3, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nystagmograph
- Device Class
- Class II
- Regulation Number
- 882.1460
- Review Panel
- NE
- Submission Type