Data / Medical devices / United States / O2 Concepts, LLC
O2 Concepts, LLC: FDA-registered device maker in Middlebury, CT, United States, 1 510(k) clearance
O2 Concepts, LLC is registered with the FDA (registration 3008910673) in Middlebury, CT, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 20, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008910673
- Address
- 199 Park Road Ext Ste B, Middlebury, CT, United States, 06762
- Owner or operator
- O2 Concepts, LLC (10035280)
- Roles
- Manufacturer
- First device listed
- February 13, 2019
- Registered through
- 2026
- Brand names listed
- Oxlife Freedom, Oxlife Independence, Oxlife Liberty
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Generator, Oxygen, Portable | CAW | 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 20, 2018 | K182454 | O2 Concepts Oxlife Independence Model 301-0001 | CAW | Substantially Equivalent | O2 Concepts, LLC | accessdata.fda.gov |
Compare with other makers
Updated December 20, 2018. 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.