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

    MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50

    K Number: K854581 · Decision Feb 28, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    8
    Review Days
    105

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    Basic Information

    Device Name
    MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50
    K Number
    K854581
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Machida America, Inc.
    Date Received
    November 15, 1985
    Decision Date
    February 28, 1986
    Product Code
    EOQ
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    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 Machida America, Inc.

    K Number Device Name
    K871712 MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT.
    K844834 MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE FNS-1
    K841087 FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000
    K821182 MODEL ENT-4L-FLEXIBLE NASOPHARYNGO-
    K821181 FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE #
    K812734 MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P
    K811943 MACHIDA NASOPHARYNGO-LARYNGOSCOPE