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

    EXHALE RF PROBE

    K Number: K011267 · Decision May 8, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    11
    Review Days
    12

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    Basic Information

    Device Name
    EXHALE RF PROBE
    K Number
    K011267
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Broncus Technologies, Inc.
    Date Received
    April 26, 2001
    Decision Date
    May 8, 2001
    Product Code
    EOQ
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    EOQ Bronchoscope (Flexible Or Rigid)

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    Other Clearances by Broncus Technologies, Inc.

    K Number Device Name
    K112051 LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE
    K093423 LUNGPOINT PROCEDURE PLANNING
    K091160 LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM
    K090853 YIELD TISSUE SAMPLER
    K090743 YIELD MINI DOPPLER SYSTEM
    K090095 LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM
    K013111 EXHALE PROBE
    K010649 EXHALE DOPPLER SYSTEM
    K993900 COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115
    K980046 BRONCHIAL CATHETER SYSTEM
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