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

    LASER BRONCHOSCOPE

    K Number: K831240 · Decision Jul 26, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    10
    Review Days
    102

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    Basic Information

    Device Name
    LASER BRONCHOSCOPE
    K Number
    K831240
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Eder Instrument Co, Inc.
    Date Received
    April 15, 1983
    Decision Date
    July 26, 1983
    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 Eder Instrument Co, Inc.

    K Number Device Name
    K843498 BIPOLAR SUCTION ELECTRODE
    K843497 SURGICAL KNIVES & PROBES
    K843499 ARTHROSCOPY LEG HOLDER
    K831255 LARYNGOSCOPE ATTACHMENT PH2000
    K831241 LASER LAPARAXOPE
    K822959 ENDOSCOPIC VIDEOSYSTEM
    K802479 SURGICAL KNIVES & PROBES
    K792100 GRASPING FORCEP (W/FOUR PRONGS)
    K791052 ENDOSCOPIC INSTRUMENT