Data / Medical devices / Canada / Mespere Lifesciences Inc.
Mespere Lifesciences Inc.: FDA-registered device maker in Waterloo Ontario, Canada, 2 510(k) clearances
Mespere Lifesciences Inc. is registered with the FDA (registration 3010521858) in Waterloo Ontario, Canada. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 26, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010521858
- Address
- 180 Columbia Street West, Units 1A & 1B, Waterloo Ontario, Canada, N2L 3L3
- Owner or operator
- Mespere LifeSciences Inc. (10045163)
- Roles
- Manufacturer
- First device listed
- November 4, 2015
- Registered through
- 2026
- Brand names listed
- Mespere LifeSciences inc., Mespere VENUS 2000
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cerebral Oximeter | QEM | 2 | Manufacturer | accessdata.fda.gov |
| Non-Invasive Central Venous Manometer | PFA | 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 26, 2018 | K182242 | VO200 NeurOs Cerebral Oximetry System | QEM | Substantially Equivalent | Mespere Lifesciences, Inc. | accessdata.fda.gov |
| August 12, 2015 | K151776 | Central Venous Pressure System | PFA | Substantially Equivalent | Mespere Lifesciences, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 26, 2018. 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.