510(k) K941262

MARQUETTE DEFIB ELECTRODE by Marquette Electronics, Inc. — Product Code MKJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 20, 1995
Date Received: March 16, 1994
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 Marquette Electronics, Inc.

K971868 — IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM (November 13, 1997)
K971683 — WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET (October 22, 1997)
K972199 — SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS (September 25, 1997)
K962547 — CARDIOSERV P (March 6, 1997)
K963120 — RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM (February 28, 1997)
K962827 — ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU) (February 24, 1997)
K964750 — EAGLE 4000 PATIENT MONITOR (February 21, 1997)
K962551 — CARDIOSERV S (November 19, 1996)
K960418 — EAGLE PATIENT MONITOR (October 2, 1996)
K960272 — EAGLE 3000/3100 PATIENT MONITOR (October 2, 1996)

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)