Cardiac Science Corporation
Cardiac Science Corporation holds FDA 510(k) medical device clearances, first cleared 2006, most recent 2015, with 2 FDA device recalls on record.
Top product codes for Cardiac Science Corporation
FDA recalls by Cardiac Science Corporation
- Z-1938-2019 — Powerheart¿ G5 Automatic AED
- Z-0829-2016 — 9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging. The AED electrodes are used for emergency treatment of cardiac arrest patients over 8 years of age or greater than 55 pounds. The user assesses the patient s condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Cardiac Science Corporation
- K143714 — Powerheart G5 AED
- K122758 — POWERHEART G5 AED
- K113176 — MYSENSE HEART
- K102496 — POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS
- K093211 — CARECENTER MD
- K091943 — POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A
- K082090 — 9131 DEFIBRILLATION ELECTRODES
- K082173 — Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S
- K060934 — MODIFICATION TO POWERHEART ECD
- K060167 — ATRIA 3100, ATRIA 6100
Data sourced from openFDA. This site is unofficial and independent of the FDA.