BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000

    K Number: K950856 · Decision Dec 29, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    83
    Applicant Total
    33
    Review Days
    305

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000
    K Number
    K950856
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5550
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Zoll Medical Corp
    Date Received
    February 27, 1995
    Decision Date
    December 29, 1995
    Product Code
    DRO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DRO), ordered by most recent decision date.

    LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PORTABLE INTENSIVE CARE UNIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Zoll Medical Corp

    K Number Device Name
    K133484 ZOLL X SERIES
    K112660 POCKETCPR
    K090989 ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES
    K042007 ZOLL E SERIES DEFIBRILLATOR
    K042302 ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE
    K042417 ZOLL M SERIES ETC02 LOFLO OPTION
    K033474 ZOLL AED PLUS
    K032691 ZOLL AUTOCLAVABLE INTERNAL HANDLES
    K032439 ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)
    K032363 ZOLL M SERIES NIBP OPTION
    Search all 33 clearances from Zoll Medical Corp →