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

    Stryker Maestro Air Motors

    K Number: K150801 · Decision May 22, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    26
    Applicant Total
    81
    Review Days
    57

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    Basic Information

    Device Name
    Stryker Maestro Air Motors
    K Number
    K150801
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4370
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Corporation
    Date Received
    March 26, 2015
    Decision Date
    May 22, 2015
    Product Code
    HBB
    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
    HBB Motor, Drill, Pneumatic

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