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

    BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP

    K Number: K951770 · Decision Nov 16, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    60
    Applicant Total
    9
    Review Days
    213

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    Basic Information

    Device Name
    BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP
    K Number
    K951770
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1925
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biodex Medical Systems, Inc.
    Date Received
    April 17, 1995
    Decision Date
    November 16, 1995
    Product Code
    IKK
    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
    IKK System, Isokinetic Testing And Evaluation

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