Data / Medical devices / Finland / Megin OY
Megin OY: FDA-registered device maker in Espoo Uusimaa, Finland, 2 510(k) clearances
Megin OY is registered with the FDA (registration 9680891) in Espoo Uusimaa, Finland. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 15, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680891
- FEI number
- 3006563303
- Address
- Keilasatama 5, Espoo Uusimaa, Finland, 02150
- Owner or operator
- Megin Oy (10058907)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 8, 2018
- Registered through
- 2026
- Brand names listed
- Elekta Neuromag® TRIUX, Elekta Neuromag® TRIUX (NM25000N), MEGreview, TRIUX neo, TRIUX neo (NM26000N), TRIUX neo (NM27000N)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Magnetoencephalograph | OLY | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Source Localization Software For Electroencephalograph Or Magnetoencephalograph | OLX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 15, 2024 | K233985 | TRIUX neo (NM27000N ); MEGreview (SW26241N-B) | OLX | Substantially Equivalent | Megin OY | accessdata.fda.gov |
| October 26, 2010 | K091393 | ELEKTA NEUROMAG WITH MAXFILTER | OLX | Substantially Equivalent | Elekta Neuromag OY | accessdata.fda.gov |
Compare with other makers
- All makers of Magnetoencephalograph
- All makers of Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Updated May 15, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.