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FDA 510(k)

SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL

K-Number: K081371 · 2008-09-24

ApplicantLeonhard Lang GmbH
Decision Date2008-09-24
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL is the device name listed in this FDA 510(k) record. The listed applicant is Leonhard Lang GmbH. It received FDA 510(k) clearance on 2008-09-24 under 510(k) number K081371. 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 SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL?

SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL is a medical device that received FDA 510(k) clearance on 2008-09-24. The listed applicant is Leonhard Lang GmbH. The 510(k) number is K081371.

When did SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL receive FDA 510(k) clearance?

SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL received FDA 510(k) clearance on 2008-09-24, under 510(k) number K081371.

Who is the listed applicant for SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL?

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

What is the FDA product code for SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL?

The FDA product code for SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL is MKJ. This falls under the Dental category.

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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.

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