Data / Medical devices / United States / Incoba LLC Dba Dynaris
Incoba LLC Dba Dynaris: FDA-registered device maker in Chesterfield, MO, United States, 1 510(k) clearance
Incoba LLC Dba Dynaris is registered with the FDA (registration 3017865349) in Chesterfield, MO, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 14, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017865349
- Address
- 743 Spirit 40 Park Dr Ste 108, Chesterfield, MO, United States, 63005
- Owner or operator
- Incoba LLC dba Dynaris (10079838)
- Roles
- Manufacturer
- First device listed
- December 30, 2020
- Registered through
- 2026
- Brand names listed
- Oxygen Conserver Apogee
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Conserver, Oxygen | NFB | 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 |
|---|---|---|---|---|---|---|
| November 14, 2020 | K200401 | Apogee | NFB | Substantially Equivalent | Incoba Ltd D/B/A Dynaris | accessdata.fda.gov |
Compare with other makers
Updated November 14, 2020. 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.