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510(k) K022929

PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210 by Cardiac Science, Inc. — Product Code MKJ

K022929 is an FDA 510(k) premarket notification submitted by Cardiac Science, Inc. for the device "PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210". The FDA issued a decision of Substantially Equivalent on Jan 27, 2003. The device falls under product code MKJ (Automated External Defibrillators (Non-Wearable)), a Class III device regulated under 21 CFR 870.5310. Cardiac Science, Inc. has 10 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 27, 2003
Date Received
Sep 4, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Automated External Defibrillators (Non-Wearable)
Device Class
Class III
Regulation Number
870.5310
Review Panel
CV
Submission Type
PMA

This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold with prescription only.

Other clearances by Cardiac Science, Inc.

  • K052316 — POWERHEART ECD (Jan 3, 2006)
  • K052161 — POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A) (Oct 21, 2005)
  • K040637 — POWERHEART AED G3 PRO (Aug 6, 2004)
  • K040438 — POWERHEART AED G3A (Jul 1, 2004)
  • K031987 — POWERHEART AED G3, MODEL 9300 (Jul 30, 2003)
  • K022210 — MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650 (Oct 4, 2002)
  • K012197 — POWERHEART CARDIAC RHYTHM MODULE (Nov 16, 2001)
  • K993533 — POWERHEART AECD (Jan 24, 2000)
  • K982710 — AECD ARRHYTHMIA DETECTION SOFTWARE (Aug 10, 1998)
  • K970741 — POWERHEART AECD (Oct 16, 1997)

Other clearances for product code MKJ

  • K143714 — Powerheart G5 AED (May 4, 2015)
  • K150055 — OneStep Pediatric CPR Multi-Function Electrode (May 2, 2015)
  • K150198 — CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel (May 2, 2015)
  • K142709 — samaritan PAD 450P (Mar 27, 2015)
  • K133659 — HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING (Jan 23, 2015)
  • K133239 — ZOLL E SERIES (Jan 16, 2015)
  • K142430 — LIFEPAK 15 monitor/defibrillator (Dec 19, 2014)
  • K141795 — BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 (Dec 8, 2014)
  • K142915 — ZOLL X Series (Dec 3, 2014)
  • K142803 — Skintact, various other tradenames (Dec 2, 2014)

FDA data resources

Source: FDA 510(k) database entry for K022929. Report a data issue: hello@regdatalab.com.