MEGreview™ SW26241N
by Megin Oy
MEGreview™ SW26241N is a Class II device made by Megin Oy, cleared under FDA 510(k) K233985 on 15 May 2024 and listed in FDA GUDID since 23 May 2025 (UDI-DI 06430056480404), active as of 22 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 | Number06430056480404 | Date23 May 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK233985 | Date15 May 2024 | StatusActive |
Official records
- AccessGUDID record 06430056480404
- FDA 510(k) database K233985
Across registries
- FDA 510(k) K233985 decided 15 May 2024 Active
- FDA GUDID UDI-DI 06430056480404 listed 23 May 2025 Listed
Timeline
- Cleared FDA 510(k) K233985
- Listed FDA GUDID 06430056480404
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MEGreview™
- Generic name
- Magnetoencephalography system, superconducting
- Model / reference
- SW26241N
- Primary DI / UDI-DI
- 06430056480404
- 510(k) Number
- FDA product code
- OLY, OLX
- GMDN term
- Magnetoencephalography system, superconducting
- Device class
- Class II
- Regulation number
- 882.1400
- GUDID distribution status
- In Commercial Distribution
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