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510(k) K091943

POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A by Cardiac Science Corporation — Product Code MKJ

K091943 is an FDA 510(k) premarket notification submitted by Cardiac Science Corporation for the device "POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A". The FDA issued a decision of Substantially Equivalent on September 10, 2009. The device falls under product code MKJ (Automated External Defibrillators (Non-Wearable)), a Class III device regulated under 21 CFR 870.5310. Cardiac Science Corporation has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2009
Date Received
June 30, 2009
Clearance Type
Special
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

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 Corporation

  • K143714 — Powerheart G5 AED (May 4, 2015)
  • K122758 — POWERHEART G5 AED (February 12, 2014)
  • K113176 — MYSENSE HEART (December 21, 2011)
  • K102496 — POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 (June 9, 2011)
  • K093211 — CARECENTER MD (June 3, 2010)
  • K082090 — 9131 DEFIBRILLATION ELECTRODES (December 12, 2008)
  • K082173 — Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S (August 26, 2008)
  • K060934 — MODIFICATION TO POWERHEART ECD (May 15, 2006)
  • K060167 — ATRIA 3100, ATRIA 6100 (April 19, 2006)

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 (March 27, 2015)
  • K133659 — HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING (January 23, 2015)
  • K133239 — ZOLL E SERIES (January 16, 2015)
  • K142430 — LIFEPAK 15 monitor/defibrillator (December 19, 2014)
  • K141795 — BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 (December 8, 2014)
  • K142915 — ZOLL X Series (December 3, 2014)
  • K142803 — Skintact, various other tradenames (December 2, 2014)

FDA data resources