Data / Medical devices / Canada / Levo Medical Corporation
Levo Medical Corporation: FDA-registered device maker in Victoria British Columbia, Canada, 1 510(k) clearance
Levo Medical Corporation is registered with the FDA (registration 3020982310) in Victoria British Columbia, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 18, 2014. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3020982310
- Address
- 455 Boleskine Road, Victoria British Columbia, Canada, V8Z 1E7
- Owner or operator
- Levo Medical Corporation (10083337)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 11, 2021
- Registered through
- 2026
- Brand names listed
- Levo System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Masker, Tinnitus | KLW | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| July 18, 2014 | K140845 | LEVO TINNITUS MASKING SOFTWARE DEVICE | KLW | Substantially Equivalent | Otoharmonics Corp | accessdata.fda.gov |
Compare with other makers
Updated July 18, 2014. 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.