Neuron-Spectrum-3
Neuron-Spectrum-3 is a Class II device made by Neurosoft, Ooo, cleared under FDA 510(k) K133995 on 19 Jun 2015 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 04650075330111), 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 | Number04650075330111 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK133995 | Date19 Jun 2015 | StatusActive |
Official records
- AccessGUDID record 04650075330111
- FDA 510(k) database K133995
Across registries
- FDA 510(k) K133995 decided 19 Jun 2015 Active
- FDA GUDID UDI-DI 04650075330111 listed 22 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K133995
- Listed FDA GUDID 04650075330111
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Neuron-Spectrum
- Generic name
- Electroencephalograph
- Model / reference
- Neuron-Spectrum-3
- Primary DI / UDI-DI
- 04650075330111
- 510(k) Number
- FDA product code
- GWQ, OLV, OLT
- GMDN term
- Electroencephalograph
- Device class
- Class II
- Regulation number
- 882.1400
- GUDID distribution status
- In Commercial Distribution
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