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FDA 510(k)

MULTI-FUNCTION DEFIBRILLATION ELECTRODE

K-Number: K002079 · 2001-02-22

ApplicantMedicotest A/S
Decision Date2001-02-22
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MULTI-FUNCTION DEFIBRILLATION ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Medicotest A/S. It received FDA 510(k) clearance on 2001-02-22 under 510(k) number K002079. 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 MULTI-FUNCTION DEFIBRILLATION ELECTRODE?

MULTI-FUNCTION DEFIBRILLATION ELECTRODE is a medical device that received FDA 510(k) clearance on 2001-02-22. The listed applicant is Medicotest A/S. The 510(k) number is K002079.

When did MULTI-FUNCTION DEFIBRILLATION ELECTRODE receive FDA 510(k) clearance?

MULTI-FUNCTION DEFIBRILLATION ELECTRODE received FDA 510(k) clearance on 2001-02-22, under 510(k) number K002079.

Who is the listed applicant for MULTI-FUNCTION DEFIBRILLATION ELECTRODE?

The FDA 510(k) record lists Medicotest A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTI-FUNCTION DEFIBRILLATION ELECTRODE?

The FDA product code for MULTI-FUNCTION DEFIBRILLATION ELECTRODE 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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