510(k) K243709
K243709 is an FDA 510(k) premarket notification submitted by Neuroears, Inc. for the device "NeuroEars-Anna". The FDA issued a decision of Substantially Equivalent on August 25, 2025. 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
- August 25, 2025
- Date Received
- December 2, 2024
- 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