Data / Medical devices / Sweden / Fogless International AB
Fogless International AB: FDA-registered device maker in Vaggeryd Jonkoping, Sweden, 1 510(k) clearance
Fogless International AB is registered with the FDA (registration 3014054118) in Vaggeryd Jonkoping, Sweden. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 23, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014054118
- Address
- Storgatan 24, Vaggeryd Jonkoping, Sweden, SE567 32
- Owner or operator
- Fogless International AB (10055703)
- Roles
- Manufacturer
- First device listed
- October 20, 2017
- Registered through
- 2026
- Brand names listed
- SPIRO Humidifier, SPIRO Speaking Valve, SPIRO Tweezer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condenser, Heat And Moisture (Artificial Nose) | BYD | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Manufacturer | accessdata.fda.gov |
| Tube Tracheostomy And Tube Cuff | JOH | 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 |
|---|---|---|---|---|---|---|
| December 23, 2013 | K122932 | SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT | JOH | Substantially Equivalent | Fogless International AB | accessdata.fda.gov |
Compare with other makers
- All makers of Condenser, Heat And Moisture (Artificial Nose)
- All makers of Tube Tracheostomy And Tube Cuff
- All makers of Forceps, General & Plastic Surgery
Updated December 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.