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

    CO2 LASER BRONCHOSCOPE SET

    K Number: K870063 · Decision Mar 9, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    9
    Review Days
    61

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    Basic Information

    Device Name
    CO2 LASER BRONCHOSCOPE SET
    K Number
    K870063
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Tti Medical
    Date Received
    January 7, 1987
    Decision Date
    March 9, 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 Tti Medical

    K Number Device Name
    K952006 ACCU-BEAM FIBER OPTIC HANDPIECE
    K951895 ACCU-BEAM 300W XENON LIGHT SOURCE
    K945648 ACCU-BEAM C02 LASER HANDPIECE
    K921208 ACCU-BEAM TUBE SET
    K910978 ACCU-BEAM LAPAROSCOPIC SYSTEM
    K895656 ACCU-BEAM WAVEGUIDE
    K890922 ACCU-BEAM YAG FIBER
    K870046 DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET