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510(k) K880932

MRL PACETTE, 450SLL by Medical Research Laboratories, Inc. — Product Code DRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1988
Date Received
March 7, 1988
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)
  • K974034 — PORTABLE INTENSIVE CARE UNIT (March 2, 1998)
  • K952085 — DPD DEFIBRILLATOR (June 5, 1995)
  • K935922 — 360 SLX ADVISORY DEFIBRILLATOR (December 22, 1994)

Other clearances for product code DRO

  • K012218 — LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES (October 12, 2001)
  • K012404 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 (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)
  • K974034 — PORTABLE INTENSIVE CARE UNIT (March 2, 1998)
  • 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)
  • K950856 — ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY (December 29, 1995)