510(k) K223047
K223047 is an FDA 510(k) premarket notification submitted by Neurobit Technologies Co., Ltd. for the device "NeuroSwift Pro". The FDA issued a decision of Substantially Equivalent on June 29, 2023. 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
- June 29, 2023
- Date Received
- September 29, 2022
- 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