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

    CO2 FIBEROPTIC DELIVERY SYSTEM/BRONCHOSCOPIC USE

    K Number: K862835 · Decision Feb 5, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    54
    Review Days
    195

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    Basic Information

    Device Name
    CO2 FIBEROPTIC DELIVERY SYSTEM/BRONCHOSCOPIC USE
    K Number
    K862835
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Cooper Lasersonics, Inc.
    Date Received
    July 25, 1986
    Decision Date
    February 5, 1987
    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 Cooper Lasersonics, Inc.

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    K880428 ILLUMINA 25 CO2 LASER SYSTEM
    K880808 ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU
    K880809 ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU
    K880171 MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL
    K880170 MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS
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    K880172 MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA.
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