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

    H&H EMERGENCY CRICOTHYROTOMY KIT

    K Number: K133528 · Decision Jul 3, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    107
    Applicant Total
    1
    Review Days
    230

    Basic Information

    Device Name
    H&H EMERGENCY CRICOTHYROTOMY KIT
    K Number
    K133528
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    H&H MEDICAL CORPORATION
    Date Received
    November 15, 2013
    Decision Date
    July 3, 2014
    Product Code
    JOH
    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
    JOH Tube Tracheostomy And Tube Cuff

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