Company ยท CA
Cardiocomm Solutions, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2019. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 22, 2019 | K181310 | HeartCheck Cardi Beat ECG Monitor with GEMS Mobile Cardiocomm Solutions, Inc., CA | DXH |
| Feb 11, 2014 | K122632 | GUAVA II Cardiocomm Solutions, Inc. | DPS |
| May 17, 2012 | K121009 | HEARTCHECK ECG PEN WITH GEMS HOME Cardiocomm Solutions, Inc. | DPS |
| Dec 22, 2011 | K111159 | HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME Cardiocomm Solutions, Inc. | DPS |
| Oct 7, 2011 | K111320 | GLOBALCARDIO Cardiocomm Solutions, Inc. | DSH |
| Oct 31, 2003 | K033037 | MODIFICATION TO GLOBALCARDIO Cardiocomm Solutions, Inc., CA | DSH |
| Sep 27, 2002 | K022297 | GLOBAL ECG MANAGEMENT SYSTEM (GEMS) Cardiocomm Solutions, Inc., CA | DSH |
| Apr 30, 2002 | K020366 | GLOBAL ECG MANAGEMENT SYSTEM (GEMS) Cardiocomm Solutions, Inc., CA | DPS |
| Jan 31, 2002 | K013354 | GLOBALCARDIO Cardiocomm Solutions, Inc., CA | DSH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||