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FDA 510(k)

SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES

K-Number: K103186 · 2011-02-08

ApplicantLeonhard Lang GmbH
Decision Date2011-02-08
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES 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 2011-02-08 under 510(k) number K103186. 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 RADIOTRANSPARENT MULTIFUNCTION ELECTRODES?

SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES is a medical device that received FDA 510(k) clearance on 2011-02-08. The listed applicant is Leonhard Lang GmbH. The 510(k) number is K103186.

When did SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES receive FDA 510(k) clearance?

SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES received FDA 510(k) clearance on 2011-02-08, under 510(k) number K103186.

Who is the listed applicant for SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES?

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 RADIOTRANSPARENT MULTIFUNCTION ELECTRODES?

The FDA product code for SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES is MKJ. This falls under the Dental category.

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Other records listing Leonhard Lang GmbH as applicant

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.

K092291SKINTACT AND VARIOUS OTHER TRADENAMESK081371SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GELK080106SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVEK073104SKINTACT AND VARIOUS OTHER TRADENAMESK072233SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORSK063161SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL

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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.

K131550HEART SYNCHeart Sync, Inc.K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical SystemsK131494HEART SYNCHeart Sync, Inc.K130454LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITORPhysio-Control, Inc.K123881HEARTSINE SAMARITAN PAD 350PHeartsine Technologies, Inc.K130153HEARSTART MRX WITH AIRWAY CONFIMRATION ASSISTPhilips Medical Systems

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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