BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PATIENT POSITIONING SYSTEM 1D OR 2D

    K Number: K800223 · Decision Mar 3, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    27
    Applicant Total
    1
    Review Days
    28

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    Basic Information

    Device Name
    PATIENT POSITIONING SYSTEM 1D OR 2D
    K Number
    K800223
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.5780
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Laboratoire National D'Essais
    Date Received
    February 4, 1980
    Decision Date
    March 3, 1980
    Product Code
    IWE
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IWE Monitor, Patient Position, Light-Beam

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