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HeartStart MRX with Q-CPR Option, Models M3535A or M3536A

FDA 510(k)

Class III (US FDA 510(k))

510(k) K051134

by Philips Medical Systems

Identifiers

510(k) Number
K051134 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 HeartStart MRX with Q-CPR Option is an Automated External Defibrillator (Non-Wearable), designed to deliver defibrillation therapy and monitor cardiac rhythms in cardiac arrest situations. It provides automated voice prompts and visual guidance to assist responders in performing effective cardiopulmonary resuscitation (CPR) and defibrillation, enhancing the likelihood of survival for victims of sudden cardiac arrest.

This device is intended for use in pre-hospital and in-hospital settings by trained responders, including emergency medical services (EMS) personnel and healthcare professionals. Supplied as a reusable medical device, it requires proper training for operation and maintenance. The HeartStart MRX is classified as a Class III device under FDA regulations and has received FDA 510(k) clearance for substantial equivalence. Models M3535A and M3536A are specifically authorized under this classification.

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
Philips Medical Systems

Sources (1)

  • FDA 510(k) K051134 24 fields · synced Sep 18, 2026