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Lifepak 300 Automatic Advisory Defrillator

FDA 510(k)

Class III (US FDA 510(k))

510(k) K925936

by Physio-Control Corp.

Identifiers

510(k) Number
K925936 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 LifePak 300 Automatic Advisory Defibrillator is an automated external defibrillator (non-wearable) designed to deliver electrical shocks for the treatment of cardiac arrest. It provides voice prompts and a full LCD display to guide users through resuscitation procedures, including advisory energy levels for defibrillation.

This device is intended for single-use or reusable applications in pre-hospital and emergency settings, depending on configuration. It operates with a monophasic damped sinusoidal waveform and delivers manual or advisory energy levels ranging from 5 to 360 joules. The device holds FDA 510(k) clearance (K925936) under the classification of Class III medical devices, adhering to regulatory standards for cardiovascular applications.

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. Sources consulted: LIFEPAK 300 - Shock Value, 1991: LifePak 300 - EMS Museum, Physio-Control - LifePak 300 Community, Manuals and ... - MedWrench, Lifepak 300 Automatic Advisory Defibrillator Inservice Video

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Physio-Control Corp.

Sources (1)

  • FDA 510(k) K925936 24 fields · synced Sep 18, 2026