Medical Device Manufacturer · CA , Victoria, B.C.

Cardiocomm Solutions, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2002

9

Total

9

Cleared

0

Denied

FDA 510(k) cleared devices by Cardiocomm Solutions, Inc. Cardiovascular ✕

9 devices

1-9 of 9

Cleared Feb 22, 2019

HeartCheck Cardi Beat ECG Monitor with GEMS Mobile

Cardiovascular · 281d

Cleared Feb 11, 2014

Cardiovascular · 531d

Cleared May 17, 2012

HEARTCHECK ECG PEN WITH GEMS HOME

Cardiovascular · 44d

Cleared Dec 22, 2011

HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME

Cardiovascular · 241d

Cleared Oct 07, 2011

Cardiovascular · 150d

Cleared Oct 31, 2003

MODIFICATION TO GLOBALCARDIO

Cardiovascular · 32d

Cleared Sep 27, 2002

GLOBAL ECG MANAGEMENT SYSTEM (GEMS)

Cardiovascular · 73d

Cleared Apr 30, 2002

GLOBAL ECG MANAGEMENT SYSTEM (GEMS)

Cardiovascular · 85d

Cleared Jan 31, 2002

Cardiovascular · 114d