Data / Medical devices / Canada / Ems Surplus Canada
Ems Surplus Canada: FDA-registered device maker in Sombra Ontario, Canada, 2 510(k) clearances
Ems Surplus Canada is registered with the FDA (registration 3010839093) in Sombra Ontario, Canada. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated May 22, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010839093
- Address
- 2811 St Clair Parkway, Sombra Ontario, Canada, N0P 2H0
- Owner or operator
- EMS SURPLUS CANADA (10051308)
- Roles
- Exporter to the US
- First device listed
- March 1, 2016
- Registered through
- 2026
- Brand names listed
- Stryker LP15 defibrillator, Zoll X series Defibrillator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated External Defibrillators (Non-Wearable) | MKJ | 3 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| May 22, 2014 | K133269 | ZOLL X SERIES | MKJ | Substantially Equivalent | Zoll Medical Corporation, World Wide Headquarters | accessdata.fda.gov |
| March 22, 2011 | K103567 | LIFEPAK 15 MONITOR/DEFIBRILLATOR | MKJ | Substantially Equivalent | Physio-Control, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 22, 2014. 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.