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FDA 510(k)

POWERHEART AED G3, MODEL 9300

K-Number: K031987 · 2003-07-30

ApplicantCardiac Science
Decision Date2003-07-30
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POWERHEART AED G3, MODEL 9300 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Science. It received FDA 510(k) clearance on 2003-07-30 under 510(k) number K031987. 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 9300?

POWERHEART AED G3, MODEL 9300 is a medical device that received FDA 510(k) clearance on 2003-07-30. The listed applicant is Cardiac Science. The 510(k) number is K031987.

When did POWERHEART AED G3, MODEL 9300 receive FDA 510(k) clearance?

POWERHEART AED G3, MODEL 9300 received FDA 510(k) clearance on 2003-07-30, under 510(k) number K031987.

Who is the listed applicant for POWERHEART AED G3, MODEL 9300?

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

What is the FDA product code for POWERHEART AED G3, MODEL 9300?

The FDA product code for POWERHEART AED G3, MODEL 9300 is MKJ. This falls under the Dental category.

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Related Devices (Code: MKJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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