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

    PRIMADO

    K Number: K083112 · Decision Apr 29, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    25
    Applicant Total
    40
    Review Days
    190

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    Basic Information

    Device Name
    PRIMADO
    K Number
    K083112
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4360
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nakanishi, Inc.
    Date Received
    October 21, 2008
    Decision Date
    April 29, 2009
    Product Code
    HBC
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HBC Motor, Drill, Electric

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