Data / Medical devices / Sweden / Nuvoair AB
Nuvoair AB: FDA-registered device maker in Stockholm, Sweden, 2 510(k) clearances
Nuvoair AB is registered with the FDA (registration 3013744763) in Stockholm, Sweden. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated January 18, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013744763
- Address
- Riddargatan 17D 3 tr, Stockholm, Sweden, 11457
- Owner or operator
- NuvoAir AB (10063987)
- Roles
- Exporter to the US, Specification developer
- First device listed
- March 23, 2020
- Registered through
- 2026
- Brand names listed
- Air Next
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Spirometer, Diagnostic | BZG | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| January 18, 2024 | K231416 | Air Next (NVD-02) | BZG | Substantially Equivalent | Nuvoair AB | accessdata.fda.gov |
| January 2, 2020 | K183089 | Air Next | BZG | Substantially Equivalent | Nuvoair AB | accessdata.fda.gov |
Compare with other makers
Updated January 18, 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.