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

    THERAPAX DXT 300 MODEL HF-300

    K Number: K973315 · Decision Dec 2, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    52
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    THERAPAX DXT 300 MODEL HF-300
    K Number
    K973315
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5900
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pantak, Inc.
    Date Received
    September 3, 1997
    Decision Date
    December 2, 1997
    Product Code
    JAD
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JAD System, Therapeutic, X-Ray

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