Data / Medical devices / Canada / Mimosa Diagnostics Inc.
Mimosa Diagnostics Inc.: FDA-registered device maker in Toronto Ontario, Canada, 1 510(k) clearance
Mimosa Diagnostics Inc. is registered with the FDA (registration 3021337298) in Toronto Ontario, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 1, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021337298
- Address
- Unit 434, 366 Adelaide St East, Toronto Ontario, Canada, M5A3X9
- Owner or operator
- MIMOSA Diagnostics Inc. (10083796)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 3, 2022
- Registered through
- 2026
- Brand names listed
- MIMOSA Pro (previously Imager)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Oximeter, Tissue Saturation | MUD | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| November 1, 2019 | K190334 | MIMOSA Imager | MUD | Substantially Equivalent | Mimosa Diagnostics, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 1, 2019. 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.