Data / Medical devices / Canada / CPR Medical Devices Inc.
CPR Medical Devices Inc.: FDA-registered device maker in Markham Ontario, Canada, 1 510(k) clearance
CPR Medical Devices Inc. is registered with the FDA (registration 9681209) in Markham Ontario, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 17, 1995. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9681209
- FEI number
- 3002628192
- Address
- 161 Don Park Road, Markham Ontario, Canada, L3R 1C2
- Owner or operator
- CPR MEDICAL DEVICES, INC. (9061682)
- Roles
- Manufacturer
- First device listed
- December 19, 2007
- Registered through
- 2026
- Brand names listed
- Oxylator®, Oxylator® EM100, Oxylator® EMX, Oxylator® FR, Oxylator® HD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ventilator, Emergency, Powered (Resuscitator) | BTL | 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 |
|---|---|---|---|---|---|---|
| April 17, 1995 | K944349 | OXYLATOR EM-100 | BTL | Substantially Equivalent | Cpr Medical Devices, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 17, 1995. 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.