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

    PK-AC POWERED PATIENT MANUPULATING DEVICE

    K Number: K854058 · Decision Feb 25, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    20
    Applicant Total
    1
    Review Days
    145

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    Basic Information

    Device Name
    PK-AC POWERED PATIENT MANUPULATING DEVICE
    K Number
    K854058
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5500
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Mannesmann Demag Corp.
    Date Received
    October 3, 1985
    Decision Date
    February 25, 1986
    Product Code
    FNG
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FNG Lift, Patient, Ac-Powered

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