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SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21

K041883 Class III Traditional
Decision Date
2004-09-07
Sponsor / Applicant
Leonhard Lang GmbH

Technical Specification

510(k) Submission ID K041883
Product Code MKJ
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.5310
Decision Date 2004-09-07
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 received FDA 510(k) clearance under submission number K041883, sponsored by Leonhard Lang GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-09-07.

Classification & Regulation

This clearance is catalogued under FDA product code MKJ and 21 CFR 870.5310, within the Cardiovascular review panel as a Class III device.