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

    PEAK FLOW RATE METER

    K Number: K893827 · Decision Aug 11, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    16
    Applicant Total
    2
    Review Days
    79

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    Basic Information

    Device Name
    PEAK FLOW RATE METER
    K Number
    K893827
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1800
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Laytech Medical Co.
    Date Received
    May 24, 1989
    Decision Date
    August 11, 1989
    Product Code
    FFG
    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
    FFG Device, Urine Flow Rate Measuring, Non-Electrical, Disposable

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    Other Clearances by Laytech Medical Co.

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