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

    TRACH MATE

    K Number: K834265 · Decision Jan 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    18
    Applicant Total
    1
    Review Days
    27

    Basic Information

    Device Name
    TRACH MATE
    K Number
    K834265
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5280
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    TEMPE BIOMEDICAL, INC.
    Date Received
    December 8, 1983
    Decision Date
    January 4, 1984
    Product Code
    JAY
    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
    JAY Support, Breathing Tube

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