BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580

    K Number: K031375 · Decision Nov 20, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    10
    Review Days
    204

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    Basic Information

    Device Name
    BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580
    K Number
    K031375
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Besmed Health Business Corp
    Date Received
    April 30, 2003
    Decision Date
    November 20, 2003
    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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