Data / Medical devices / Sweden / Seebreath AB
Seebreath AB: FDA-registered device maker in Stockholm, Sweden, 1 510(k) clearance
Seebreath AB is registered with the FDA (registration 3009754460) in Stockholm, Sweden. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 13, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009754460
- Address
- Birger Jarlsgatan 2, Stockholm, Sweden, 11434
- Owner or operator
- SeeBreath AB (10041602)
- Roles
- Specification developer
- First device listed
- August 10, 2012
- Registered through
- 2026
- Brand names listed
- CapnoDura Combi, CapnoDura Pedi
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | 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 |
|---|---|---|---|---|---|---|
| July 13, 2012 | K112840 | CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR | CCK | Substantially Equivalent | Seebreath AB | accessdata.fda.gov |
Compare with other makers
Updated July 13, 2012. 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.