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

    PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA

    K Number: K901032 · Decision Apr 4, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    9
    Review Days
    29

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    Basic Information

    Device Name
    PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA
    K Number
    K901032
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Accucore, Inc.
    Date Received
    March 6, 1990
    Decision Date
    April 4, 1990
    Product Code
    DPS
    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
    DPS Electrocardiograph

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    Other Clearances by Accucore, Inc.

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    K896775 PCI MODEL 2041-B TELEMETRY MONITOR
    K894340 PCI MODEL 2041-A TELEMETRY MONITOR
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