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510(k) K950856

ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000 by Zoll Medical Corp — Product Code DRO

K950856 is an FDA 510(k) premarket notification submitted by Zoll Medical Corp for the device "ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000". The FDA issued a decision of Substantially Equivalent on December 29, 1995. The device falls under product code DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)), a Class II device regulated under 21 CFR 870.5550. Zoll Medical Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1995
Date Received
February 27, 1995
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 Zoll Medical Corp

  • K133484 — ZOLL X SERIES (August 1, 2014)
  • K112660 — POCKETCPR (May 10, 2012)
  • K090989 — ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES (September 23, 2009)
  • K042007 — ZOLL E SERIES DEFIBRILLATOR (April 7, 2005)
  • K042302 — ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTE (October 26, 2004)
  • K042417 — ZOLL M SERIES ETC02 LOFLO OPTION (October 5, 2004)
  • K033474 — ZOLL AED PLUS (May 21, 2004)
  • K032691 — ZOLL AUTOCLAVABLE INTERNAL HANDLES (November 13, 2003)
  • K032439 — ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) (November 5, 2003)
  • K032363 — ZOLL M SERIES NIBP OPTION (October 31, 2003)

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)
  • 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)
  • K951593 — LIFEPAK 11 (December 29, 1995)

FDA data resources