Data / Medical devices / Sweden / Airsonett AB
Airsonett AB: FDA-registered device maker in Angelholm Skane, Sweden, 1 510(k) clearance
Airsonett AB is registered with the FDA (registration 3004793042) in Angelholm Skane, Sweden. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 23, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004793042
- Address
- Kelliehousevagen 31, Angelholm Skane, Sweden, 26274
- Owner or operator
- Airsonett AB (10027949)
- Roles
- Manufacturer
- First device listed
- December 17, 2013
- Registered through
- 2026
- Brand names listed
- Airsonett
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cleaner, Air, Medical Recirculating | FRF | 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 23, 2013 | K130702 | AIRSONETT AIR-4 | FRF | Substantially Equivalent | Airsonett AB | accessdata.fda.gov |
Compare with other makers
Updated July 23, 2013. 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.