Cleared Traditional

PORTABLE INTENSIVE CARE UNIT

K974034 · Medical Research Laboratories, Inc. · Cardiovascular
Mar 1998
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K974034 is an FDA 510(k) clearance for the PORTABLE INTENSIVE CARE UNIT, a Pacemaker, Cardiac, External Transcutaneous (non-invasive) (Class II — Special Controls, product code DRO), submitted by Medical Research Laboratories, Inc. (Buffalo Grove, US). The FDA issued a Cleared decision on March 2, 1998, 130 days after receiving the submission on October 23, 1997. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5550.

Submission Details

510(k) Number K974034 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 1997
Decision Date March 02, 1998
Days to Decision 130 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DRO — Pacemaker, Cardiac, External Transcutaneous (non-invasive)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5550

Similar Devices — DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)

All 83
LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES
K012218 · The Ludlow Company LP · Oct 2001
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
K012404 · Katecho, Inc. · Oct 2001
ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413
K000660 · Medical Data Electronics · Mar 2000
PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
K983196 · Tz Medical, Inc. · Sep 1999
PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT
K983232 · Tz Medical, Inc. · Sep 1999
CARDIOSERV P
K962547 · Marquette Electronics, Inc. · Mar 1997