Cleared Traditional

MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER

K895525 · Matrix Medica, Inc. · Cardiovascular
Jan 1990
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K895525 is an FDA 510(k) clearance for the MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER, a Tester, Defibrillator (Class II — Special Controls, product code DRL), submitted by Matrix Medica, Inc. (Orchard Park, US). The FDA issued a Cleared decision on January 26, 1990, 136 days after receiving the submission on September 12, 1989. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5325.

Submission Details

510(k) Number K895525 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 1989
Decision Date January 26, 1990
Days to Decision 136 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DRL — Tester, Defibrillator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5325