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

    OPTUS SINUSCOPES AND ACCESSORIES

    K Number: K944656 · Decision Jan 26, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    161
    Applicant Total
    10
    Review Days
    127

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    Basic Information

    Device Name
    OPTUS SINUSCOPES AND ACCESSORIES
    K Number
    K944656
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4760
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Optus, Inc.
    Date Received
    September 21, 1994
    Decision Date
    January 26, 1995
    Product Code
    EOB
    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
    EOB Nasopharyngoscope (Flexible Or Rigid)

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    Other Clearances by Optus, Inc.

    K Number Device Name
    K945264 OPTUS OTOSCOPES
    K953913 OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES
    K945268 OPTUS BRONCHOSCOPES
    K945265 OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES
    K945262 OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES
    K945267 OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES
    K945266 OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES
    K945263 OPTUS THORACOSCOPES
    K945269 OPTUS LARYNGOSCOPES