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Automated External Defibrillators (Non-Wearable)

FDA product code MKJ · 211 cleared devices

Class 3 Cardiovascular
Regulation
21 CFR 870.5310
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1985-10-11 – 2013-12-06

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.

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