21 CFR 870.5310 — Automated External Defibrillators (Non-Wearable)
Cardiovascular (CV) · Part 870 Subpart F—Cardiovascular Therapeutic Devices · § 870.5310
Identification
An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.
Classification Rationale
Class III (premarket approval)
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | 3 | 245 | |
| NSA | Over-The-Counter Automated External Defibrillator | 3 | 2 | Life-Sustaining |
