Data / Medical devices / Switzerland / Elfo AG
Elfo AG: FDA-registered device maker in Sachseln Obwalden, Switzerland, 1 510(k) clearance
Elfo AG is registered with the FDA (registration 1000154583) in Sachseln Obwalden, Switzerland. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 22, 2017. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1000154583
- Address
- Edisriederstrasse 106, Sachseln Obwalden, Switzerland, 6072
- Owner or operator
- elfo ag (10058377)
- Roles
- Manufacturer
- First device listed
- September 7, 2018
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator, Predicted Values, Pulmonary Function | BTY | 2 | Manufacturer | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | 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 |
|---|---|---|---|---|---|---|
| February 22, 2017 | K161534 | EasyOne Pro Respiratory Analysis System | BTY | Substantially Equivalent | Ndd Medizintechnik AG | accessdata.fda.gov |
Compare with other makers
Updated February 22, 2017. 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.