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Lifepak 8

FDA 510(k)

Class II (US FDA 510(k))

510(k) K842624

by Physio-Control Corp.

Identifiers

510(k) Number
K842624 FDA 510(k)
FDA Product Code
LDD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.5300 FDA 510(k)
Regulation Number
870.5300 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Lifepak 8 is a low-energy DC defibrillator that includes paddles for cardiac resuscitation. It is designed to provide diagnostic-quality ECG recording and features both demand and non-demand pacing capabilities.

This device is regulated as a Class 2 medical device under regulation number 870.5300. It has received FDA 510(k) clearance through a traditional submission process.

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: Physio-Control - LifePak 8 Community, Manuals and Specifications ..., Physio-Control - LifePak 8 Manuals and Documents | Medical, Lifepak 8 User and Service Manual - Archive.org, Physio-Control - Wikipedia, Physio Control Lifepak 8 Defibrillator - Service and User Manual

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) K842624 24 fields · synced Sep 23, 2026