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

    THE SIGNATURE SERIES, IC II

    K Number: K933196 · Decision Jul 12, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    10
    Review Days
    376

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    Basic Information

    Device Name
    THE SIGNATURE SERIES, IC II
    K Number
    K933196
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Progressive Electrical Therapeutics
    Date Received
    July 1, 1993
    Decision Date
    July 12, 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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    K933194 THE SIGNATURE SERIES, IMC IV
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