Data / Medical devices / Canada / Thorasys Thoracic Medical Systems Inc.
Thorasys Thoracic Medical Systems Inc.: FDA-registered device maker in Montreal Quebec, Canada, 2 510(k) clearances
Thorasys Thoracic Medical Systems Inc. is registered with the FDA (registration 3011331794) in Montreal Quebec, Canada. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 20, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3011331794
- Address
- 6560 Avenue de l'Esplanade suite 103, Montreal Quebec, Canada, H2V4L5
- Owner or operator
- THORASYS Thoracic Medical Systems inc. (10056503)
- Roles
- Manufacturer
- First device listed
- December 15, 2017
- Registered through
- 2026
- Brand names listed
- TremoFlo C-100 Airwave Oscillometry System, tremoflo C2 Airwave Oscillometry System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Impedance Measuring Device Utilizing Oscillation Techniques | PNV | 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 |
|---|---|---|---|---|---|---|
| June 20, 2023 | K221024 | tremoflo C2 Airwave Oscillometry System | PNV | Substantially Equivalent | Thorasys Thoracic Medical Systems, Inc. | accessdata.fda.gov |
| September 12, 2017 | K170185 | tremoFlo C-100 Airwave Oscillometry System | PNV | Substantially Equivalent | Thorasys Thoracic Medical Systems, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 20, 2023. 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.