(1) As used in this part, unless the context otherwise requires:(1) “AED” or “defibrillator” means an automated external defibrillator; and(2) “Automated external defibrillator (AED)” means a medical device heart monitor and defibrillator that:(A) Has received approval of its premarket notification, filed pursuant to 21 U.S.C. § 360(R), from the United States food and drug administration;(B) Is capable of recognizing the presence or absence of ventricular fibrillation or rapid ventricular tachycardia, and is capable of determining, without intervention by an operator, whether defibrillation should be performed; and(C) Upon determining that defibrillation should be performed, automatically charges and requests delivery of an electrical impulse to an individual’s heart.
(1) “AED” or “defibrillator” means an automated external defibrillator; and
(2) “Automated external defibrillator (AED)” means a medical device heart monitor and defibrillator that:(A) Has received approval of its premarket notification, filed pursuant to 21 U.S.C. § 360(R), from the United States food and drug administration;(B) Is capable of recognizing the presence or absence of ventricular fibrillation or rapid ventricular tachycardia, and is capable of determining, without intervention by an operator, whether defibrillation should be performed; and(C) Upon determining that defibrillation should be performed, automatically charges and requests delivery of an electrical impulse to an individual’s heart.
(A) Has received approval of its premarket notification, filed pursuant to 21 U.S.C. § 360(R), from the United States food and drug administration;
(B) Is capable of recognizing the presence or absence of ventricular fibrillation or rapid ventricular tachycardia, and is capable of determining, without intervention by an operator, whether defibrillation should be performed; and
(C) Upon determining that defibrillation should be performed, automatically charges and requests delivery of an electrical impulse to an individual’s heart.