Part Definitions

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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:
    1. Has received approval of its premarket notification, filed pursuant to 21 U.S.C. § 360(R), from the United States food and drug administration;
    2. 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
    3. Upon determining that defibrillation should be performed, automatically charges and requests delivery of an electrical impulse to an individual’s heart.


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