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

    HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR

    K Number: K950483 · Decision May 22, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    83
    Applicant Total
    230
    Review Days
    108

    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
    HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR
    K Number
    K950483
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5550
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hewlett-Packard Co.
    Date Received
    February 3, 1995
    Decision Date
    May 22, 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 Hewlett-Packard Co.

    K Number Device Name
    K992543 HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE
    K993587 HP M2376A DEVICE LINK SYSTEM
    K993169 MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
    K992977 HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A
    K993516 HP M2600A VIRIDIA TELEMETRY SYSTEM
    K993171 HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A
    K992636 HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A
    K991871 HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A
    K984194 HP M2376A DEVICE LINK SYSTEM
    K990400 LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM
    Search all 230 clearances from Hewlett-Packard Co. →