FDA 510(k)

POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A

K-Number: K091943 · 2009-09-10

Decision Date2009-09-10

Product CodeMKJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Science Corporation. It received FDA 510(k) clearance on 2009-09-10 under 510(k) number K091943. 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 POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A?

POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A is a medical device that received FDA 510(k) clearance on 2009-09-10. The listed applicant is Cardiac Science Corporation. The 510(k) number is K091943.

When did POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A receive FDA 510(k) clearance?

POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A received FDA 510(k) clearance on 2009-09-10, under 510(k) number K091943.

Who is the listed applicant for POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A?

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

What is the FDA product code for POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A?

The FDA product code for POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A is MKJ. This falls under the Dental category.

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Other records listing Cardiac Science Corporation as applicant

K113176MYSENSE HEART K102496POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS K093211CARECENTER MD K0820909131 DEFIBRILLATION ELECTRODES K082173Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S K060934MODIFICATION TO POWERHEART ECD

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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.