BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA.

    K Number: K880172 · Decision Mar 11, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    54
    Review Days
    56

    Basic Information

    Device Name
    MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA.
    K Number
    K880172
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    COOPER LASERSONICS, INC.
    Date Received
    January 15, 1988
    Decision Date
    March 11, 1988
    Product Code
    LKW
    Advisory Committee
    Unknown
    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
    LKW Laser, Neurosurgical

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