Medical Device Manufacturer · US , Bothell , WA

Cardiac Science Corporation - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2006

10

Total

10

Cleared

0

Denied

Cardiac Science Corporation — FDA 510(k) Products and Clearance History Cardiovascular ✕

10 devices

1-10 of 10

Cleared May 04, 2015

Powerheart G5 AED

Cardiovascular · 126d

Cleared Feb 12, 2014

POWERHEART G5 AED

Cardiovascular · 520d

Cleared Dec 21, 2011

Cardiovascular · 54d

Cleared Jun 09, 2011

POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED...

Cardiovascular · 282d

Cleared Jun 03, 2010

Cardiovascular · 233d

Cleared Sep 10, 2009

POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A

Cardiovascular · 72d

Cleared Dec 12, 2008

9131 DEFIBRILLATION ELECTRODES

Cardiovascular · 141d

Cleared Aug 26, 2008

Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S

Cardiovascular · 25d

Cleared May 15, 2006

MODIFICATION TO POWERHEART ECD

Cardiovascular · 40d

Cleared Apr 19, 2006

ATRIA 3100, ATRIA 6100

Cardiovascular · 86d