Medical Device Manufacturer · US , Bothell , WA

Cardiac Science Corporation

10 submissions · 10 cleared · Since 2006
10
Total
10
Cleared
0
Denied

Cardiac Science Corporation — FDA 510(k) Submissions

Cardiac Science Corporation has submitted 10 FDA 510(k) premarket notifications since 2006, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Automated External Defibrillators (non-wearable), Electrocardiograph, Recorder, Magnetic Tape, Medical . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
Powerheart G5 AED
K143714 · MKJ Automated External... · Cardiovascular
May 2015 126d
POWERHEART G5 AED
K122758 · MKJ Automated External... · Cardiovascular
Feb 2014 520d
MYSENSE HEART
K113176 · DSH Recorder, Magnetic Tape,... · Cardiovascular
Dec 2011 54d
POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS
K102496 · MKJ Automated External... · Cardiovascular
Jun 2011 282d
CARECENTER MD
K093211 · DPS Electrocardiograph · Cardiovascular
Jun 2010 233d
POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A
K091943 · MKJ Automated External... · Cardiovascular
Sep 2009 72d
9131 DEFIBRILLATION ELECTRODES
K082090 · MKJ Automated External... · Cardiovascular
Dec 2008 141d
Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S
K082173 · DPS Electrocardiograph · Cardiovascular
Aug 2008 25d
MODIFICATION TO POWERHEART ECD
K060934 · MKJ Automated External... · Cardiovascular
May 2006 40d
ATRIA 3100, ATRIA 6100
K060167 · DPS Electrocardiograph · Cardiovascular
Apr 2006 86d
Filters
All10 Cardiovascular 10