Data / Medical devices / United States / Oxyhealth, LLC
Oxyhealth, LLC: FDA-registered device maker in Santa Fe Springs, CA, United States, 2 510(k) clearances
Oxyhealth, LLC is registered with the FDA (registration 3006777109) in Santa Fe Springs, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated November 15, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006777109
- Address
- 10719 Norwalk Blvd, Santa Fe Springs, CA, United States, 90670
- Owner or operator
- OxyHealth, LLC (10031555)
- Roles
- Repackager or relabeler
- First device listed
- February 12, 2010
- Registered through
- 2026
- Brand names listed
- Fortius 420, Fortius 420 EXP, Quamvis 320, Respiro 270, Solace 210, Vitaeris 320
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chamber, Hyperbaric | CBF | 2 | Repackager or relabeler | 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 15, 2004 | K041007 | MILLENIUM, MODELS 2000, 2001 AND 2002 | CBF | Substantially Equivalent | Hyperbaric For Life, LLC | accessdata.fda.gov |
| August 2, 2000 | K001409 | GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER | CBF | Substantially Equivalent | Hyperbaric Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 15, 2004. 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.