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

    BC 1400 HAND POSITIONER

    K Number: K872316 · Decision Aug 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    355
    Applicant Total
    45
    Review Days
    56

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    Basic Information

    Device Name
    BC 1400 HAND POSITIONER
    K Number
    K872316
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Instrumentation Industries, Inc.
    Date Received
    June 17, 1987
    Decision Date
    August 12, 1987
    Product Code
    KPR
    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
    KPR System, X-Ray, Stationary

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