(b) "Automated external defibrillator", hereinafter referred to as AED, means a medical device heart monitor and defibrillator that:
- (1) Has undergone the premarket approval process pursuant to the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360, as amended;
- (2) is capable of recognizing the presence or absence of ventricular fibrillation;
- (3) is capable of determining, without intervention by the operator, whether defibrillation should be performed; and (4) upon determining that defibrillation should be performed, automatically charges and requests delivery of an electrical impulse to an individual's heart.