MKJ · Class III — High Risk (PMA approval required, life-sustaining) · Cardiovascular · 21 CFR 870.5310
Classification
FDA Product Code
MKJ
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
21 CFR 870.5310
Review panel
CV
Medical specialty
Cardiovascular
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.