Cardiocomm Solutions, Inc.
North York Ontario, CA
CARDIOCOMM SOLUTIONS, INC. appears in FDA device records in North York Ontario, CA. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Cardiocomm Solutions, Inc. between 2002 and 2019. The busiest year on record is 2002, with 3. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 3 |
| 2003 | 1 |
| 2011 | 2 |
| 2012 | 1 |
| 2014 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K181310 | HeartCheck Cardi Beat ECG Monitor with GEMS Mobile | DXH | Substantially Equivalent | |
| K122632 | GUAVA II | DPS | Substantially Equivalent | |
| K121009 | HEARTCHECK ECG PEN WITH GEMS HOME | DPS | Substantially Equivalent | |
| K111159 | HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME | DPS | Substantially Equivalent | |
| K111320 | GLOBALCARDIO | DSH | Substantially Equivalent | |
| K033037 | MODIFICATION TO GLOBALCARDIO | DSH | Substantially Equivalent | |
| K022297 | GLOBAL ECG MANAGEMENT SYSTEM (GEMS) | DSH | Substantially Equivalent | |
| K020366 | GLOBAL ECG MANAGEMENT SYSTEM (GEMS) | DPS | Substantially Equivalent | |
| K013354 | GLOBALCARDIO | DSH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9680510 | 3003708031 | CARDIOCOMM SOLUTIONS, INC. | 110 Sheppard Avenue East Suite 700, North York Ontario M2N 6Y8 CA | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain