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

    FLEXVIEW CO2 BLOWER WITH MIST

    K Number: K973803 · Decision Dec 16, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    52
    Applicant Total
    111
    Review Days
    71

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    Basic Information

    Device Name
    FLEXVIEW CO2 BLOWER WITH MIST
    K Number
    K973803
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5475
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ethicon Endo-Surgery, Inc.
    Date Received
    October 6, 1997
    Decision Date
    December 16, 1997
    Product Code
    FQH
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FQH Lavage, Jet

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