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

    9105 RIGID TELESCOPIC ENDOSCOPE

    K Number: K921285 · Decision May 28, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    7
    Applicant Total
    5
    Review Days
    72

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    Basic Information

    Device Name
    9105 RIGID TELESCOPIC ENDOSCOPE
    K Number
    K921285
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4750
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kay Elemetrics Corp.
    Date Received
    March 17, 1992
    Decision Date
    May 28, 1992
    Product Code
    EQL
    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
    EQL Laryngostroboscope

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    Other Clearances by Kay Elemetrics Corp.

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