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

    PCI MODEL 2041-B TELEMETRY MONITOR

    K Number: K896775 · Decision May 17, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    9
    Review Days
    167

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    Basic Information

    Device Name
    PCI MODEL 2041-B TELEMETRY MONITOR
    K Number
    K896775
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Accucore, Inc.
    Date Received
    December 1, 1989
    Decision Date
    May 17, 1990
    Product Code
    DSI
    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
    DSI Detector And Alarm, Arrhythmia

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    Other Clearances by Accucore, Inc.

    K Number Device Name
    K942147 PACIFIC COMMUNICATIONS MODEL 1100
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    K913400 MODEL SCR-1000
    K901031 PCI MODEL 2041-PC TELEMETRY MONITOR
    K901032 PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA
    K894340 PCI MODEL 2041-A TELEMETRY MONITOR
    K874387 PCI MODEL RS100 TELEMETRY MONITOR