FDA 510(k)

INFANT/CHILD REDUCED ENERGY ELECTRODES

K-Number: K022732 · 2002-12-13

Decision Date2002-12-13

Product CodeMKJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

INFANT/CHILD REDUCED ENERGY ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Physio-Control Corp.. It received FDA 510(k) clearance on 2002-12-13 under 510(k) number K022732. 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 INFANT/CHILD REDUCED ENERGY ELECTRODES?

INFANT/CHILD REDUCED ENERGY ELECTRODES is a medical device that received FDA 510(k) clearance on 2002-12-13. The listed applicant is Medtronic Physio-Control Corp.. The 510(k) number is K022732.

When did INFANT/CHILD REDUCED ENERGY ELECTRODES receive FDA 510(k) clearance?

INFANT/CHILD REDUCED ENERGY ELECTRODES received FDA 510(k) clearance on 2002-12-13, under 510(k) number K022732.

Who is the listed applicant for INFANT/CHILD REDUCED ENERGY ELECTRODES?

The FDA 510(k) record lists Medtronic Physio-Control Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFANT/CHILD REDUCED ENERGY ELECTRODES?

The FDA product code for INFANT/CHILD REDUCED ENERGY ELECTRODES is MKJ. This falls under the Dental category.

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Other records listing Medtronic Physio-Control Corp. as applicant

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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.