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

    STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302

    K Number: K942694 · Decision Mar 10, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    14
    Applicant Total
    9
    Review Days
    276

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    Basic Information

    Device Name
    STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302
    K Number
    K942694
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.1575
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biodex Medical Systems, Inc.
    Date Received
    June 7, 1994
    Decision Date
    March 10, 1995
    Product Code
    KHX
    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
    KHX Platform, Force-Measuring

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