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510(k) K041883

SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 by Leonhard Lang GmbH — Product Code MKJ

K041883 is an FDA 510(k) premarket notification submitted by Leonhard Lang GmbH for the device "SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21". The FDA issued a decision of Substantially Equivalent on September 7, 2004. The device falls under product code MKJ (Automated External Defibrillators (Non-Wearable)), a Class III device regulated under 21 CFR 870.5310. Leonhard Lang GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2004
Date Received
July 12, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated External Defibrillators (Non-Wearable)
Device Class
Class III
Regulation Number
870.5310
Review Panel
CV
Submission Type

This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold with prescription only.

Other clearances by Leonhard Lang GmbH

  • K142803 — Skintact, various other tradenames (December 2, 2014)
  • K140500 — SKINTACT (July 29, 2014)
  • K140340 — SKINTACT (May 21, 2014)
  • K103186 — SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES (February 8, 2011)
  • K092291 — SKINTACT AND VARIOUS OTHER TRADENAMES (August 21, 2009)
  • K081371 — SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL (September 24, 2008)
  • K080106 — SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE (February 1, 2008)
  • K073104 — SKINTACT AND VARIOUS OTHER TRADENAMES (November 16, 2007)
  • K072233 — SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMP (October 5, 2007)
  • K063161 — SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL (November 21, 2006)

Other clearances for product code MKJ

  • K143714 — Powerheart G5 AED (May 4, 2015)
  • K150055 — OneStep Pediatric CPR Multi-Function Electrode (May 2, 2015)
  • K150198 — CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel (May 2, 2015)
  • K142709 — samaritan PAD 450P (March 27, 2015)
  • K133659 — HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING (January 23, 2015)
  • K133239 — ZOLL E SERIES (January 16, 2015)
  • K142430 — LIFEPAK 15 monitor/defibrillator (December 19, 2014)
  • K141795 — BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 (December 8, 2014)
  • K142915 — ZOLL X Series (December 3, 2014)
  • K142803 — Skintact, various other tradenames (December 2, 2014)

FDA data resources