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

    Uroflowmeter

    K Number: K142425 · Decision Oct 27, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    59

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    Basic Information

    Device Name
    Uroflowmeter
    K Number
    K142425
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1800
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Be Technologies, Inc.
    Date Received
    August 29, 2014
    Decision Date
    October 27, 2014
    Product Code
    EXY
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EXY Uroflowmeter

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