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

    PACEPAC

    K Number: K852958 · Decision Oct 11, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    83
    Applicant Total
    27
    Review Days
    91

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    Basic Information

    Device Name
    PACEPAC
    K Number
    K852958
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5550
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medical Data Electronics
    Date Received
    July 12, 1985
    Decision Date
    October 11, 1985
    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)

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    Other Clearances by Medical Data Electronics

    K Number Device Name
    K014294 MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414
    K012336 MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500
    K000660 ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413
    K992413 ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR
    K992411 ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR
    K982104 ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500
    K970763 MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR
    K970011 ESCORT II CLINICAL THERMOMETRY MODULE (CTM)
    K970012 ESCORT LINK CENTRAL STATION MONITOR
    K961138 ESORT II + 400 SERIES MONITOR
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