510(k) K003228

K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A by Katecho, Inc. — Product Code MKJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 14, 2000
Date Received: October 16, 2000
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 Katecho, Inc.

K012404 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 (October 12, 2001)
K010543 — KM-30 TENS ELECTRODE (May 23, 2001)
K002806 — K-DEFIB/PACE, MODEL KDP-60A (November 21, 2000)
K000870 — KM-10 TENS ELECTRODE (November 7, 2000)
K993745 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80 (February 3, 2000)
K991007 — K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 (August 23, 1999)
K981737 — K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60 (December 9, 1998)
K954504 — K-DEFIB/PACE PEDIATRIC ELECTRODE (November 17, 1995)
K934692 — K-DEFIB/PACE PEDIATRIC ELECTRODE (January 24, 1995)
K940801 — K-KLIP (August 3, 1994)

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)