Data / Medical devices / United Kingdom / Cumulus Neuroscience
Cumulus Neuroscience: FDA-registered device maker in Belfast Antrim and Newtownabbey, United Kingdom, 1 510(k) clearance
Cumulus Neuroscience is registered with the FDA (registration 3020223448) in Belfast Antrim and Newtownabbey, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 27, 2023. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3020223448
- Address
- Concourse 3, Unit 5, Queens Road, Belfast Antrim and Newtownabbey, United Kingdom, BT3 9DT
- Owner or operator
- Cumulus Neuroscience (10090933)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- June 4, 2024
- Registered through
- 2027
- Brand names listed
- Cumulus Functional Neurophysiology Platform
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Full-Montage Standard Electroencephalograph | GWQ | 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 |
|---|---|---|---|---|---|---|
| April 27, 2023 | K221963 | Cumulus Functional Neurophysiology Platform | GWQ | Substantially Equivalent | Cumulus Neuroscience Limited | accessdata.fda.gov |
Compare with other makers
Updated April 27, 2023. 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.