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 ↓

Total

Cleared

Denied

Cardiac Science, Inc. has 8 FDA 510(k) cleared cardiovascular devices. Based in Minnetonka, US.

Historical record: 8 cleared submissions from 1997 to 2006.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

Cardiac Science, Inc. is one of 20359 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

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

10 devices

1-10 of 10

Cleared Jan 03, 2006

POWERHEART ECD

K052316 · MKJ

Cardiovascular · 131d

Cleared Oct 21, 2005

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

K052161 · MKJ

Cardiovascular · 73d

Cleared Aug 06, 2004

POWERHEART AED G3 PRO

K040637 · MKJ

Cardiovascular · 149d

Cleared Jul 01, 2004

POWERHEART AED G3A

K040438 · MKJ

Cardiovascular · 133d

Cleared Jan 27, 2003

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

K022929 · MKJ

Cardiovascular · 145d

Cleared Oct 04, 2002

MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650

K022210 · MKJ

Cardiovascular · 88d

Cleared Nov 16, 2001

POWERHEART CARDIAC RHYTHM MODULE

K012197 · MKJ

Cardiovascular · 126d

AECD ARRHYTHMIA DETECTION SOFTWARE

Cardiovascular · 230d

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

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

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