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510(k) K974034

PORTABLE INTENSIVE CARE UNIT by Medical Research Laboratories, Inc. — Product Code DRO

K974034 is an FDA 510(k) premarket notification submitted by Medical Research Laboratories, Inc. for the device "PORTABLE INTENSIVE CARE UNIT". The FDA issued a decision of Substantially Equivalent on March 2, 1998. The device falls under product code DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)), a Class II device regulated under 21 CFR 870.5550. Medical Research Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1998
Date Received
October 23, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Device Class
Class II
Regulation Number
870.5550
Review Panel
CV
Submission Type

Other clearances by Medical Research Laboratories, Inc.

  • K021168 — JUMP START, MODEL 970300 (June 26, 2002)
  • K012766 — PORTABLE INTENSIVE CARE UNIT (January 23, 2002)
  • K012030 — PORTABLE INTENSIVE CARE UNIT (September 24, 2001)
  • K010207 — PORTABLE INSTENSIVE CARE UNIT (June 14, 2001)
  • K002232 — AEDEFIBRILLATOR (December 6, 2000)
  • K000712 — PORTABLE INTENSIVE CARE UNIT, MODEL PIC (April 27, 2000)
  • K983307 — MODIFICATION TO PORTABLE INTENSIVE CARE UNIT (November 20, 1998)
  • K952085 — DPD DEFIBRILLATOR (June 5, 1995)
  • K935922 — 360 SLX ADVISORY DEFIBRILLATOR (December 22, 1994)
  • K930548 — DPD DEFIBRILLATOR (June 25, 1993)

Other clearances for product code DRO

  • K012404 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 (October 12, 2001)
  • K012218 — LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES (October 12, 2001)
  • K000660 — ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS (March 28, 2000)
  • K983196 — PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) (September 15, 1999)
  • K983232 — PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2 (September 15, 1999)
  • K962547 — CARDIOSERV P (March 6, 1997)
  • K963120 — RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM (February 28, 1997)
  • K961138 — ESORT II + 400 SERIES MONITOR (December 10, 1996)
  • K951593 — LIFEPAK 11 (December 29, 1995)
  • K950856 — ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY (December 29, 1995)

FDA data resources