BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TRU-MR LARYNGOSCOPE SET

    K Number: K062523 · Decision Nov 17, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    63
    Applicant Total
    2
    Review Days
    81

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    Basic Information

    Device Name
    TRU-MR LARYNGOSCOPE SET
    K Number
    K062523
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5540
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Truphatek International, Ltd.
    Date Received
    August 28, 2006
    Decision Date
    November 17, 2006
    Product Code
    CCW
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CCW Laryngoscope, Rigid

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    Other Clearances by Truphatek International, Ltd.

    K Number Device Name
    K063309 TRU-CABLE