Data / Medical devices / United States / MicroVapor Devices, LLC
MicroVapor Devices, LLC: FDA-registered device maker in West Columbia, SC, United States, 1 510(k) clearance
MicroVapor Devices, LLC is registered with the FDA (registration 3011528328) in West Columbia, SC, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 22, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011528328
- Address
- 4500 12th Street Extension, West Columbia, SC, United States, 29172
- Owner or operator
- MicroVapor Devices, LLC (10049050)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- July 20, 2016
- Registered through
- 2026
- Brand names listed
- Pocket Neb, X-Hale Mask
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mask, Oxygen | BYG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 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 |
|---|---|---|---|---|---|---|
| January 22, 2016 | K142541 | POCKET NEB | CAF | Substantially Equivalent | Microvaper Devices | accessdata.fda.gov |
Compare with other makers
Updated January 22, 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.