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

    PIRD-Y

    K Number: K842262 · Decision Jun 28, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    21

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    Basic Information

    Device Name
    PIRD-Y
    K Number
    K842262
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Pirdy, Inc.
    Date Received
    June 7, 1984
    Decision Date
    June 28, 1984
    Product Code
    ISB
    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
    ISB Stimulator, Muscle, Diagnostic

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