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

    COMPEX 2

    K Number: K940301 · Decision Dec 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    9
    Review Days
    338

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    Basic Information

    Device Name
    COMPEX 2
    K Number
    K940301
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Biodex Medical Systems, Inc.
    Date Received
    January 24, 1994
    Decision Date
    December 28, 1994
    Product Code
    IPF
    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
    IPF Stimulator, Muscle, Powered

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