Vivosonic Inc.
TORONTO Ontario, CA
VIVOSONIC INC. appears in FDA device records in TORONTO Ontario, CA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Vivosonic Inc. between 2001 and 2024. The busiest year on record is 2001, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2003 | 1 |
| 2005 | 1 |
| 2008 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242954 | Integrity V500 (Integrity, Integrity with VEMP) | GWJ | Substantially Equivalent | |
| K080060 | VIVOSONIC NEUROSCREEN | GWJ | Substantially Equivalent | |
| K043396 | INTEGRITY, MODEL V500 | GWJ | Substantially Equivalent | |
| K033108 | VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER | EWO | Substantially Equivalent | |
| K003364 | VIVO 200 DPS VIVOSCAN | EWO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004046843 | 3004046843 | VIVOSONIC INC. | 222-5535 EGLINTON AVENUE WEST, TORONTO Ontario M9C 5K5 CA | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain