Data / Medical devices / United States / Promaxo, LLC
Promaxo, LLC: FDA-registered device maker in Oakland, CA, United States, 1 510(k) clearance
Promaxo, LLC is registered with the FDA (registration 3014635027) in Oakland, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 3, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014635027
- Address
- 70 Washington Street Ste 407, Oakland, CA, United States, 94607
- Owner or operator
- Promaxo, LLC (10096190)
- Roles
- Specification developer
- First device listed
- July 20, 2026
- Registered through
- 2026
- Brand names listed
- Promaxo MRI System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Specification developer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 3, 2021 | K202518 | Promaxo MRI System | LNH | Substantially Equivalent | Promaxo, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of Coil, Magnetic Resonance, Specialty
Updated March 3, 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.