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

    ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM

    K Number: K946011 · Decision Feb 17, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    156
    Applicant Total
    6
    Review Days
    70

    Basic Information

    Device Name
    ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM
    K Number
    K946011
    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
    ARGUS MEDICAL CO., INC.
    Date Received
    December 9, 1994
    Decision Date
    February 17, 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 ARGUS MEDICAL CO., INC.

    K Number Device Name
    K950255 ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM
    K951624 ARGUS MEDICAL COMPANY LAPAROSCOPIC DISCECTOMY INSTRUMENT SYSTEM
    K950242 ARGUS ARTHROSCOPY INSTRUMENT SYSTEM
    K950297 ARGUS ENDOSCOPIC PLASTIC SURGERY INSTRUMENT SYSTEM
    K950378 ARGUS LAPAROSCOPY INSTRUMENT SYSTEM