BrainView NeuralScan HW9N
by Medeia Inc
BrainView NeuralScan HW9N is a Class II device made by Medeia Inc, cleared under FDA 510(k) K192753 on 17 Mar 2020 and listed in FDA GUDID since 5 Feb 2025 (UDI-DI 08690020003062), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08690020003062 | Date5 Feb 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192753 | Date17 Mar 2020 | StatusActive |
Official records
- AccessGUDID record 08690020003062
- FDA 510(k) database K192753
Across registries
- FDA 510(k) K192753 decided 17 Mar 2020 Active
- FDA GUDID UDI-DI 08690020003062 listed 5 Feb 2025 Listed
Timeline
- Cleared FDA 510(k) K192753
- Listed FDA GUDID 08690020003062
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BrainView NeuralScan
- Generic name
- Electroencephalograph
- Model / reference
- HW9N
- Primary DI / UDI-DI
- 08690020003062
- 510(k) Number
- FDA product code
- GWJ, GWQ, OLT
- GMDN term
- Electroencephalograph
- Device class
- Class II
- Regulation number
- 882.1900, 882.1400
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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