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510(k) Data Aggregation

    K Number
    K971390
    Device Name
    QUANTUM 3080SP SURGICAL TABLE
    Manufacturer
    STERIS Corporation
    Date Cleared
    1997-05-15

    (31 days)

    Product Code
    GDC
    Regulation Number
    878.4960
    Why did this record match?
    Product Code :

    GDC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K970807
    Device Name
    MOBILE OPERATING TABLE 1132.01
    Manufacturer
    STIERLEN-MAQUET AG
    Date Cleared
    1997-03-14

    (9 days)

    Product Code
    GDC
    Regulation Number
    878.4960
    Why did this record match?
    Product Code :

    GDC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is for use during diagnostic examinations or surgical procedures to support and position a patient.
    Device Description
    The operating table has been designed to fulfil the special requirements for patient positioning during surgical treatment. The side rails are provided for fitting additional parts. Before positioning the patient the device has to be covered with sheets. It is an electrohydraulical operated system which can be controlled by means of a hand control box, IR-transmitter, foot switch or with the override. Power is supplied by batteries, which can be recharged by a built-in battery charger. The operating table has the following functions: Trendelenburg / reverse Trendelenburg positioning, Lateral tilt movement (right / left), Leg plate movement (up/down), Back plate movement (up / down), Head plate movement (up / down), Hight adjustment. The table top is subdivided as follows: Head plate, removable back plate section, back plate, seat plate, leg plates. Each foam upholstered patient section is radiotranslucent and electrically conductive.
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    K Number
    K964273
    Device Name
    DURA-BOARD ARMBOARD
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Date Cleared
    1997-01-08

    (72 days)

    Product Code
    GDC, FQO, FWW
    Regulation Number
    878.4960
    Why did this record match?
    Product Code :

    GDC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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