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Heartstream Fr2 Aed, Model M3860a, M3861a

FDA 510(k)

Class III (US FDA 510(k))

510(k) K003565

by Agilent Technologies, Inc.

Identifiers

510(k) Number
K003565 FDA 510(k)
FDA Product Code
MKJ FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.5310 FDA 510(k)
Regulation Number
870.5310 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Heartstream FR2 AED is an Automated External Defibrillator (Non-Wearable), designed to deliver electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. It provides voice prompts and visual guidance to assist untrained responders in performing cardiopulmonary resuscitation (CPR) and defibrillation.

This device is supplied as a reusable medical instrument intended for use in emergency response settings, including pre-hospital and in-hospital environments. It is classified as a Class III device under FDA regulations and has received FDA 510(k) clearance through a Special 510(k) pathway, with a decision date of December 20, 2000. The device is not indicated for MRI use and must be stored in accordance with manufacturer instructions to maintain functionality.

Frequently asked questions

Is the Heartstream FR2 AED reusable or single-use, and how should it be maintained between uses in emergency settings?

The Heartstream FR2 AED is designed as a reusable medical instrument for use in emergency response environments, including pre-hospital and in-hospital settings. Since it is reusable, proper maintenance and storage are critical to ensure functionality. The manufacturer’s instructions must be followed strictly, including regular servicing, calibration, and cleaning as specified to maintain performance and reliability for repeated use in life-threatening situations.

What types of environments is the Heartstream FR2 AED intended for, and are there any restrictions on its use?

The Heartstream FR2 AED is intended for emergency response settings, including pre-hospital (e.g., ambulances, first responder units) and in-hospital environments where sudden cardiac arrest may occur. It is not indicated for MRI use, meaning it should not be placed in or near an MRI scanner, as this could interfere with the device’s operation or pose safety risks. Always store and use it according to the manufacturer’s guidelines to preserve functionality.

What are the key differences between the Heartstream FR2 AED models M3860A and M3861A?

The provided data does not specify technical or functional differences between the M3860A and M3861A models of the Heartstream FR2 AED. Both models are listed as Automated External Defibrillators (Non-Wearable) with identical regulatory pathways and intended use. For precise distinctions—such as software updates, firmware variations, or additional features—you would need to consult the manufacturer’s official documentation or contact Agilent Technologies directly.

How does the Heartstream FR2 AED assist untrained responders during a cardiac emergency?

The Heartstream FR2 AED is equipped with voice prompts and visual guidance to walk untrained responders through the steps of cardiopulmonary resuscitation (CPR) and defibrillation. This hands-free design ensures clarity and reduces the risk of errors during a critical moment, helping responders deliver appropriate shocks and maintain chest compressions effectively until professional medical help arrives.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Agilent Technologies, Inc.

Sources (1)

  • FDA 510(k) K003565 24 fields · synced Sep 18, 2026