Cleared Traditional

LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER

K895533 · Matrix Medica, Inc. · Cardiovascular
Jan 1990
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K895533 is an FDA 510(k) clearance for the LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER, a Dc-defibrillator, Low-energy, (including Paddles) (Class II — Special Controls, product code LDD), submitted by Matrix Medica, Inc. (Orchard Park, US). The FDA issued a Cleared decision on January 26, 1990, 135 days after receiving the submission on September 13, 1989. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5300.

Submission Details

510(k) Number K895533 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 1989
Decision Date January 26, 1990
Days to Decision 135 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code LDD — Dc-defibrillator, Low-energy, (including Paddles)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5300

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