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

    TALKING TRACH

    K Number: K062104 · Decision Apr 20, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    2
    Review Days
    270

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    Basic Information

    Device Name
    TALKING TRACH
    K Number
    K062104
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Engineered Medical Systems, Inc.
    Date Received
    July 24, 2006
    Decision Date
    April 20, 2007
    Product Code
    BTO
    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
    BTO Tube, Tracheostomy (W/Wo Connector)

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    Other Clearances by Engineered Medical Systems, Inc.

    K Number Device Name
    K220533 Endoscopy Oxygen Mask