Medical Device Manufacturer · US , Minnetonka , MN

Cardiac Science, Inc. - FDA 510(k) Cleared Devices

10 submissions · 8 cleared · Since 1997

Recent clearances: POWERHEART ECD, POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A), POWERHEART AED G3 PRO

View 10 510(k) Devices ↓

10

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cardiac Science, Inc. Cardiovascular ✕

10 devices

1-10 of 10

Cleared Jan 03, 2006

Cardiovascular · 131d

Cleared Oct 21, 2005

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

Cardiovascular · 73d

Cleared Aug 06, 2004

POWERHEART AED G3 PRO

Cardiovascular · 149d

Cleared Jul 01, 2004

POWERHEART AED G3A

Cardiovascular · 133d

Cleared Jan 27, 2003

PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED,...

Cardiovascular · 145d

Cleared Oct 04, 2002

MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650

Cardiovascular · 88d

Cleared Nov 16, 2001

POWERHEART CARDIAC RHYTHM MODULE

Cardiovascular · 126d

Cleared Jan 24, 2000

POWERHEART AECD

Cardiovascular · 97d

Cleared Aug 10, 1998

AECD ARRHYTHMIA DETECTION SOFTWARE

Cardiovascular · 6d

Cleared Oct 16, 1997

POWERHEART AECD

Cardiovascular · 230d