Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart F — Cardiovascular Therapeutic Devices](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices) → [21 CFR 870.5310](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5310) → NSA — Over-The-Counter Automated External Defibrillator

# NSA · Over-The-Counter Automated External Defibrillator

_Cardiovascular · 21 CFR 870.5310 · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NSA

## Overview

- **Product Code:** NSA
- **Device Name:** Over-The-Counter Automated External Defibrillator
- **Regulation:** [21 CFR 870.5310](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5310)
- **Device Class:** 3
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **Life-sustaining:** yes

## 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)

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P160029](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NSA/P160029.md) | HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) | Philips Medical Systems, Inc. | Jun 6, 2019 | APPR |
| [K040904](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NSA/K040904.md) | PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A | Philips Medical Systems | Sep 16, 2004 | SESE |

## Top Applicants

- Philips Medical Systems — 1 clearance
- Philips Medical Systems, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NSA](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NSA)

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