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

    EQUINOXE

    K Number: K980920 · Decision Jul 16, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    72
    Applicant Total
    2
    Review Days
    128

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    Basic Information

    Device Name
    EQUINOXE
    K Number
    K980920
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5100
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bouvier Hydro, Inc.
    Date Received
    March 10, 1998
    Decision Date
    July 16, 1998
    Product Code
    ILJ
    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
    ILJ Bath, Hydro-Massage

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