510(k) K012766

PORTABLE INTENSIVE CARE UNIT by Medical Research Laboratories, Inc. — Product Code MKJ

Clearance Details

Decision: ST ()
Decision Date: January 23, 2002
Date Received: August 17, 2001
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 Medical Research Laboratories, Inc.

K021168 — JUMP START, MODEL 970300 (June 26, 2002)
K012030 — PORTABLE INTENSIVE CARE UNIT (September 24, 2001)
K010207 — PORTABLE INSTENSIVE CARE UNIT (June 14, 2001)
K002232 — AEDEFIBRILLATOR (December 6, 2000)
K000712 — PORTABLE INTENSIVE CARE UNIT, MODEL PIC (April 27, 2000)
K983307 — MODIFICATION TO PORTABLE INTENSIVE CARE UNIT (November 20, 1998)
K974034 — PORTABLE INTENSIVE CARE UNIT (March 2, 1998)
K952085 — DPD DEFIBRILLATOR (June 5, 1995)
K935922 — 360 SLX ADVISORY DEFIBRILLATOR (December 22, 1994)
K930548 — DPD DEFIBRILLATOR (June 25, 1993)

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)