BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    FLAATZ 760

    K Number: K111655 · Decision Nov 30, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    355
    Applicant Total
    6
    Review Days
    170

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    Basic Information

    Device Name
    FLAATZ 760
    K Number
    K111655
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Drtech Corp.
    Date Received
    June 13, 2011
    Decision Date
    November 30, 2011
    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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    Other Clearances by Drtech Corp.

    K Number Device Name
    K132842 FLAATZ 600 SERIES (FLAATZ 600/601)
    K111583 FLAATZ 560
    K102474 FLAATZ 750E
    K091747 FLAATZ 500
    K080064 FLAATZ 750