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

    FLAATZ 500

    K Number: K091747 · Decision Jul 1, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    355
    Applicant Total
    6
    Review Days
    15

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    Basic Information

    Device Name
    FLAATZ 500
    K Number
    K091747
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Drtech Corp.
    Date Received
    June 16, 2009
    Decision Date
    July 1, 2009
    Product Code
    KPR
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    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)
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    K111583 FLAATZ 560
    K102474 FLAATZ 750E
    K080064 FLAATZ 750