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

    RICH-MAR DELTA 330 HV

    K Number: K844217 · Decision Nov 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    54
    Applicant Total
    43
    Review Days
    27

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    Basic Information

    Device Name
    RICH-MAR DELTA 330 HV
    K Number
    K844217
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Rich-Mar Corp.
    Date Received
    October 31, 1984
    Decision Date
    November 27, 1984
    Product Code
    IMG
    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
    IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

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