Data / Medical devices / Spain / Orthoapnea S.L.
Orthoapnea S.L.: FDA-registered device maker in Malaga, Spain, 2 510(k) clearances
Orthoapnea S.L. is registered with the FDA (registration 3012359952) in Malaga, Spain. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated February 25, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012359952
- Address
- C/ Flauta Magica 22, Malaga, Spain, 29006
- Owner or operator
- Orthoapnea S.L. (10080953)
- Roles
- Manufacturer
- First device listed
- March 9, 2021
- Registered through
- 2026
- Brand names listed
- CLASSIC, NOA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 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 |
|---|---|---|---|---|---|---|
| February 25, 2021 | K203477 | Classic | LRK | Substantially Equivalent | Orthoapnea S.L. | accessdata.fda.gov |
| February 12, 2021 | K202651 | NOA Sleep Apnea and Snoring Device | LRK | Substantially Equivalent | Orthoapnea S.L. | accessdata.fda.gov |
Compare with other makers
Updated February 25, 2021. 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.