Data / Medical devices / Sweden / Algodx AB
Algodx AB: FDA-registered device maker in Stockholm, Sweden, 1 510(k) clearance
Algodx AB is registered with the FDA (registration 3034211429) in Stockholm, Sweden. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 22, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3034211429
- Address
- Gotgatan 22A, Stockholm, Sweden, 118 46
- Owner or operator
- AlgoDx AB (10092080)
- Roles
- Manufacturer
- First device listed
- December 3, 2024
- Registered through
- 2026
- Brand names listed
- NAVOYCDS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Multivariate Vital Signs Index | PLB | 2 | 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 |
|---|---|---|---|---|---|---|
| July 22, 2024 | K240558 | NAVOYCDS | PLB | Substantially Equivalent | Algodx AB | accessdata.fda.gov |
Compare with other makers
Updated July 22, 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.