FDA 510(k)

SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS

K-Number: K072233 · 2007-10-05

Decision Date2007-10-05

Product CodeMKJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS 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 2007-10-05 under 510(k) number K072233. 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 MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS?

SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS is a medical device that received FDA 510(k) clearance on 2007-10-05. The listed applicant is Leonhard Lang GmbH. The 510(k) number is K072233.

When did SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS receive FDA 510(k) clearance?

SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS received FDA 510(k) clearance on 2007-10-05, under 510(k) number K072233.

Who is the listed applicant for SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS?

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 MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS?

The FDA product code for SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS is MKJ. This falls under the Dental category.

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Other records listing Leonhard Lang GmbH as applicant

K103186SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES K092291SKINTACT AND VARIOUS OTHER TRADENAMES K081371SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL K080106SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE K073104SKINTACT AND VARIOUS OTHER TRADENAMES K063161SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL

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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.