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

    CHALLENGER #450

    K Number: K830519 · Decision Apr 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    193
    Applicant Total
    2
    Review Days
    54

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    Basic Information

    Device Name
    CHALLENGER #450
    K Number
    K830519
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Transmed, Inc.
    Date Received
    February 17, 1983
    Decision Date
    April 12, 1983
    Product Code
    DSH
    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
    DSH Recorder, Magnetic Tape, Medical

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