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Lifepak 8

by Physio-Control Corp.

510(k) K842624

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK842624 Date18 Oct 1984ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LDD
Device class
Class II
Regulation
21 CFR Part 870.5300
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Similar devices

Other devices filed under FDA product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)).

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