Data / Medical devices / Canada / Cardiocomm Solutions, Inc.
Cardiocomm Solutions, Inc.: FDA-registered device maker in North York Ontario, Canada, 10 510(k) clearances
Cardiocomm Solutions, Inc. is registered with the FDA (registration 9680510) in North York Ontario, Canada. It lists 3 device types. The FDA files 10 510(k) clearances under its listings, the newest dated February 22, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680510
- FEI number
- 3003708031
- Address
- 110 Sheppard Avenue East Suite 700 Suite 700, North York Ontario, Canada, M2N 6Y8
- Owner or operator
- CardioComm Solutions, Inc. (9009563)
- Roles
- Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer
- First device listed
- October 16, 2007
- Registered through
- 2026
- Brand names listed
- GC12, GC12 Flex, GC3, GEMS Air, GEMS Auto Attendant, GEMS Flex, GEMS Flex SMART Monitoring, GEMS HL7 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocardiograph | DPS | 2 | Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Recorder, Magnetic Tape, Medical | DSH | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Complaint file establishment, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| February 22, 2019 | K181310 | HeartCheck Cardi Beat ECG Monitor with GEMS Mobile | DXH | Substantially Equivalent | Cardiocomm Solutions, Inc. | accessdata.fda.gov |
| February 11, 2014 | K122632 | GUAVA II | DPS | Substantially Equivalent | Cardiocomm Solutions, Inc. | accessdata.fda.gov |
| May 17, 2012 | K121009 | HEARTCHECK ECG PEN WITH GEMS HOME | DPS | Substantially Equivalent | Cardiocomm Solutions, Inc. | accessdata.fda.gov |
| December 22, 2011 | K111159 | HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME | DPS | Substantially Equivalent | Cardiocomm Solutions, Inc. | accessdata.fda.gov |
| October 7, 2011 | K111320 | GLOBALCARDIO | DSH | Substantially Equivalent | Cardiocomm Solutions, Inc. | accessdata.fda.gov |
| September 26, 2008 | K080933 | HANDHELD ECG MONITOR, MODEL MD100 | DPS | Substantially Equivalent | Beijing Choice Electronic Technololgy Co., Ltd. | accessdata.fda.gov |
| October 31, 2003 | K033037 | MODIFICATION TO GLOBALCARDIO | DSH | Substantially Equivalent | Cardiocomm Solutions, Inc. | accessdata.fda.gov |
| September 27, 2002 | K022297 | GLOBAL ECG MANAGEMENT SYSTEM (GEMS) | DSH | Substantially Equivalent | Cardiocomm Solutions, Inc. | accessdata.fda.gov |
| April 30, 2002 | K020366 | GLOBAL ECG MANAGEMENT SYSTEM (GEMS) | DPS | Substantially Equivalent | Cardiocomm Solutions, Inc. | accessdata.fda.gov |
| January 31, 2002 | K013354 | GLOBALCARDIO | DSH | Substantially Equivalent | Cardiocomm Solutions, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Recorder, Magnetic Tape, Medical
- All makers of Electrocardiograph
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
Updated February 22, 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.