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

    CONTROL SOLUTIONS INC, MODEL CS3101

    K Number: K993420 · Decision Jul 19, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    2
    Review Days
    281

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    Basic Information

    Device Name
    CONTROL SOLUTIONS INC, MODEL CS3101
    K Number
    K993420
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Control Solutions, Inc.
    Date Received
    October 12, 1999
    Decision Date
    July 19, 2000
    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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    Other Clearances by Control Solutions, Inc.

    K Number Device Name
    K041146 CONTROL SOLUTIONS, INC., MODEL CS3102 HVG