Data / Medical devices / Sweden / Qbtech AB
Qbtech AB: FDA-registered device maker in Stockholm, Sweden, 4 510(k) clearances
Qbtech AB is registered with the FDA (registration 3004529412) in Stockholm, Sweden. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated March 22, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004529412
- Address
- Cardellgatan 1, Stockholm, Sweden, 11436
- Owner or operator
- QBTECH AB (9062600)
- Roles
- Manufacturer
- First device listed
- November 23, 2007
- Registered through
- 2026
- Brand names listed
- QbCheck, QbTest
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Recorder, Attention Task Performance | LQD | U | 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 |
|---|---|---|---|---|---|---|
| March 22, 2016 | K143468 | QbCheck | LQD | Substantially Equivalent | Qbtech AB | accessdata.fda.gov |
| March 24, 2014 | K133382 | QB TEST | LQD | Substantially Equivalent | Qbtech AB | accessdata.fda.gov |
| October 17, 2012 | K122149 | QBTES | LQD | Substantially Equivalent | Qbtech AB | accessdata.fda.gov |
| June 22, 2004 | K040894 | QBTEST | LQD | Substantially Equivalent | Qbtech AB | accessdata.fda.gov |
Compare with other makers
Updated March 22, 2016. 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.