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

    LASER BACKPOINTER ASSEMBLY, MOD. 01-2487

    K Number: K800489 · Decision Mar 25, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    27
    Applicant Total
    2
    Review Days
    21

    Basic Information

    Device Name
    LASER BACKPOINTER ASSEMBLY, MOD. 01-2487
    K Number
    K800489
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.5780
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    ATC MEDICAL TECHNOLOGY, INC.
    Date Received
    March 4, 1980
    Decision Date
    March 25, 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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