Data / Medical devices / United States / Pulmera Inc.
Pulmera Inc.: FDA-registered device maker in Charlotte, NC, United States, 1 510(k) clearance
Pulmera Inc. is registered with the FDA (registration 3049422862) in Charlotte, NC, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 22, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3049422862
- Address
- 7th floor, 905 Pearl Parkway, Charlotte, NC, United States, 28204
- Owner or operator
- Pulmera Inc. (10096327)
- Roles
- Specification developer
- First device listed
- September 8, 2026
- Registered through
- 2026
- Brand names listed
- C-beam system
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Specification developer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 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 |
|---|---|---|---|---|---|---|
| May 22, 2026 | K252735 | C-beam | OWB | Substantially Equivalent | Pulmera, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Tomography, Computed
- All makers of Interventional Fluoroscopic X-Ray System
Updated May 22, 2026. 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.