Data / Medical devices / Iceland / Kvikna Medical ehf
Kvikna Medical ehf: FDA-registered device maker in Reykjavik, Iceland, 1 510(k) clearance
Kvikna Medical ehf is registered with the FDA (registration 3011047165) in Reykjavik, Iceland. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 21, 2015. Registered through 2026. FDA data exported November 3, 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
- 3011047165
- Address
- Lynghals 9, Reykjavik, Iceland, 110
- Owner or operator
- Kvikna Medical ehf (10051556)
- Roles
- Specification developer
- First device listed
- April 4, 2016
- Registered through
- 2026
- Brand names listed
- Stratus EEG
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Full-Montage Standard Electroencephalograph | GWQ | 2 | Specification developer | accessdata.fda.gov |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| August 21, 2015 | K143487 | Lifelines iEEG | OLT | Substantially Equivalent | Kvikna Ehf | accessdata.fda.gov |
Compare with other makers
- All makers of Non-Normalizing Quantitative Electroencephalograph Software
- All makers of Full-Montage Standard Electroencephalograph
Updated August 21, 2015. 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.