Data / Medical devices / United States / Pulmone Usa Inc
Pulmone Usa Inc: FDA-registered device maker in Carrollton, TX, United States, 1 510(k) clearance
Pulmone Usa Inc is registered with the FDA (registration 3011583549) in Carrollton, TX, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 21, 2016. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011583549
- Address
- 4100 Medical Pkwy Ste 200, Carrollton, TX, United States, 75007
- Owner or operator
- PulmOne USA INC (10049302)
- Roles
- Specification developer
- First device listed
- July 27, 2025
- Registered through
- 2027
- Brand names listed
- MiniBox+
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator, Pulmonary Function Data | BZC | 2 | Specification developer | accessdata.fda.gov |
| Spirometer, Diagnostic | BZG | 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 |
|---|---|---|---|---|---|---|
| October 21, 2016 | K161295 | MiniBox + | BZC | Substantially Equivalent | Pulmone Advanced Medical Devices, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 21, 2016. 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.