Home / Companies / Cardiac Science Corporation

Cardiac Science Corporation

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
10
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1938-2019Class IIPowerheart¿ G5 Automatic AEDJune 4, 2019
Z-0829-2016Class II9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 93January 14, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K143714Powerheart G5 AEDMay 4, 2015
K122758POWERHEART G5 AEDFebruary 12, 2014
K113176MYSENSE HEARTDecember 21, 2011
K102496POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AEDJune 9, 2011
K093211CARECENTER MDJune 3, 2010
K091943POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390ASeptember 10, 2009
K0820909131 DEFIBRILLATION ELECTRODESDecember 12, 2008
K082173Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4SAugust 26, 2008
K060934MODIFICATION TO POWERHEART ECDMay 15, 2006
K060167ATRIA 3100, ATRIA 6100April 19, 2006