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510(k) K002232

AEDEFIBRILLATOR by Medical Research Laboratories, Inc. — Product Code MKJ

K002232 is an FDA 510(k) premarket notification submitted by Medical Research Laboratories, Inc. for the device "AEDEFIBRILLATOR". The FDA issued a decision of Substantially Equivalent on December 6, 2000. The device falls under product code MKJ (Automated External Defibrillators (Non-Wearable)), a Class III device regulated under 21 CFR 870.5310. Medical Research Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2000
Date Received
July 24, 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 Medical Research Laboratories, Inc.

  • K021168 — JUMP START, MODEL 970300 (June 26, 2002)
  • K012766 — PORTABLE INTENSIVE CARE UNIT (January 23, 2002)
  • K012030 — PORTABLE INTENSIVE CARE UNIT (September 24, 2001)
  • K010207 — PORTABLE INSTENSIVE CARE UNIT (June 14, 2001)
  • 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)

FDA data resources