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

    AMBU ASCOPE 2

    K Number: K110962 · Decision Nov 18, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    38
    Review Days
    226

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    Basic Information

    Device Name
    AMBU ASCOPE 2
    K Number
    K110962
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ambu A/S
    Date Received
    April 6, 2011
    Decision Date
    November 18, 2011
    Product Code
    BTR
    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
    BTR Tube, Tracheal (W/Wo Connector)

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    Other Clearances by Ambu A/S

    K Number Device Name
    K251583 Ambu® Virobac II® Exhalation Filter
    K250269 Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)
    K240849 Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2
    K240848 Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™ 2 Advance
    K242108 Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aView™ 2 Advance
    K233630 Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2
    K233886 Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2
    K232919 Ambu® aScope™ Gastro Large; Ambu® aBox™ 2
    K233671 Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 Advance
    K232582 Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
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