LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER— 510(k) K895533

Name: FDA 510(k) clearance K895533
Creator: U.S. Food and Drug Administration
Published: 1990-01-26

Substantially Equivalent

Matrix Medica, Inc.

FDA 510(k) clearance K895533 for LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER, Substantially Equivalent on 1990-01-26. Applicant: Matrix Medica, Inc.. Device class: 2.

Clearance details

Applicant: Matrix Medica, Inc.
Product code: Code LDD
Device class: Class 2
Regulation: 21 CFR 870.5300
Advisory panel: Cardiovascular
Date received: 1989-09-13
Decision date: 1990-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orchard Park, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.