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

    THD SLIDE

    K Number: K081429 · Decision Jul 30, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    13
    Review Days
    70

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    Basic Information

    Device Name
    THD SLIDE
    K Number
    K081429
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1540
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thd Spa
    Date Received
    May 21, 2008
    Decision Date
    July 30, 2008
    Product Code
    JAF
    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
    JAF Monitor, Ultrasonic, Nonfetal

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    Other Clearances by Thd Spa

    K Number Device Name
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    K180135 THD Anopress with THD SensyProbe
    K161785 THD ANOPRESS
    K141657 THD REVOLUTION
    K133687 THD N-ANO ANOSCOPE
    K121135 THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE
    K103647 THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES
    K093497 THD BANDY
    K091490 FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES
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