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

    TAS-(VARIOUS) ULTRATHIN FLEXIBLE ENDOSCOPE

    K Number: K942388 · Decision Aug 17, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    3
    Review Days
    90

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    Basic Information

    Device Name
    TAS-(VARIOUS) ULTRATHIN FLEXIBLE ENDOSCOPE
    K Number
    K942388
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Technology Marketing Group
    Date Received
    May 19, 1994
    Decision Date
    August 17, 1994
    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 Technology Marketing Group

    K Number Device Name
    K941715 ULTATHIN FLEXIBLE ENDOSCOPE
    K935834 TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE