FDA 510(k)

PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210

K-Number: K022929 · 2003-01-27

Decision Date2003-01-27

Product CodeMKJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Science, Inc.. It received FDA 510(k) clearance on 2003-01-27 under 510(k) number K022929. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210?

PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210 is a medical device that received FDA 510(k) clearance on 2003-01-27. The listed applicant is Cardiac Science, Inc.. The 510(k) number is K022929.

When did PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210 receive FDA 510(k) clearance?

PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210 received FDA 510(k) clearance on 2003-01-27, under 510(k) number K022929.

Who is the listed applicant for PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210?

The FDA 510(k) record lists Cardiac Science, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210?

The FDA product code for PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210 is MKJ. This falls under the Dental category.

Related Clinical Trials

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Other records listing Cardiac Science, Inc. as applicant

K052316POWERHEART ECD K052161POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)K040637POWERHEART AED G3 PRO K040438POWERHEART AED G3A K022210MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650 K012197POWERHEART CARDIAC RHYTHM MODULE

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Related Devices (Code: MKJ)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.