BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MODIFIED SPANTRON FRAME FREEZE

    K Number: K895546 · Decision Nov 13, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    299
    Applicant Total
    2
    Review Days
    61

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    Basic Information

    Device Name
    MODIFIED SPANTRON FRAME FREEZE
    K Number
    K895546
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Spantron, Inc.
    Date Received
    September 13, 1989
    Decision Date
    November 13, 1989
    Product Code
    JAA
    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
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

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    Other Clearances by Spantron, Inc.

    K Number Device Name
    K890477 THE SPANTRON FRAME FREEZE