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

    PERLINK SCREEN, KIRAN SCREEN

    K Number: K896707 · Decision Aug 30, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    34
    Applicant Total
    6
    Review Days
    275

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    Basic Information

    Device Name
    PERLINK SCREEN, KIRAN SCREEN
    K Number
    K896707
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1960
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Perlink USA, Inc.
    Date Received
    November 28, 1989
    Decision Date
    August 30, 1990
    Product Code
    EAM
    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
    EAM Screen, Intensifying, Radiographic

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    Other Clearances by Perlink USA, Inc.

    K Number Device Name
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