BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HYDRA TRED DC

    K Number: K801250 · Decision Jun 17, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    20

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    Basic Information

    Device Name
    HYDRA TRED DC
    K Number
    K801250
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5370
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Medichanics, Inc.
    Date Received
    May 28, 1980
    Decision Date
    June 17, 1980
    Product Code
    IOG
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IOG Treadmill, Mechanical

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