BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN

    K Number: K844765 · Decision Apr 8, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    1
    Applicant Total
    5
    Review Days
    122

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    Basic Information

    Device Name
    ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN
    K Number
    K844765
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4420
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Laser Spectrum, Inc.
    Date Received
    December 7, 1984
    Decision Date
    April 8, 1985
    Product Code
    EWQ
    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
    EWQ Saw, Surgical, Ent (Electric Or Pneumatic)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EWQ), ordered by most recent decision date.

    FELDMAN MINI-SAW, #300000

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat
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    Other Clearances by Laser Spectrum, Inc.

    K Number Device Name
    K863520 CO2 LASER MICROMANIPULATOR
    K841781 MODEL 305AA PORTABLE LASER
    K842498 DANIELL DBL PUNCTURE LASER LAPAROSCOPY
    K841668 CO2 LAPAROSCOPE