MKJ

Automated External Defibrillators (Non-Wearable)

Product code

MKJ

Device name

Automated External Defibrillators (Non-Wearable)

Device class

Class 3

21 CFR

21 CFR 870.5310

Medical specialty

Cardiovascular

Marketing pathway

PMA

510(k) clearances (all years, FDA)

228 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).