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

    PCI MODEL 2041-PC TELEMETRY MONITOR

    K Number: K901031 · Decision May 17, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    9
    Review Days
    72

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    Basic Information

    Device Name
    PCI MODEL 2041-PC TELEMETRY MONITOR
    K Number
    K901031
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Accucore, Inc.
    Date Received
    March 6, 1990
    Decision Date
    May 17, 1990
    Product Code
    DRT
    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
    DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

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