Data / Medical devices / Canada / Vivosonic Inc.
Vivosonic Inc.: FDA-registered device maker in TORONTO Ontario, Canada, 2 510(k) clearances
Vivosonic Inc. is registered with the FDA (registration 3004046843) in TORONTO Ontario, Canada. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 19, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004046843
- Address
- Eglinton Avenue West, TORONTO Ontario, Canada, M9C 5K5
- Owner or operator
- Vivosonic Inc (9043486)
- Roles
- Manufacturer
- First device listed
- June 24, 2003
- Registered through
- 2026
- Brand names listed
- INTEGRITY, Integrity, Integrity V500
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Audiometer | EWO | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Auditory, Evoked Response | GWJ | 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 |
|---|---|---|---|---|---|---|
| December 19, 2024 | K242954 | Integrity V500 (Integrity, Integrity with VEMP) | GWJ | Substantially Equivalent | Vivosonic, Inc. | accessdata.fda.gov |
| January 24, 2005 | K043396 | INTEGRITY, MODEL V500 | GWJ | Substantially Equivalent | Vivosonic, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 19, 2024. 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.