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

    FR6000 FLOWMETER

    K Number: K884973 · Decision Jan 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    48

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    Basic Information

    Device Name
    FR6000 FLOWMETER
    K Number
    K884973
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.2340
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Key Instruments
    Date Received
    November 30, 1988
    Decision Date
    January 17, 1989
    Product Code
    CAX
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CAX Flowmeter, Tube, Thorpe, Back-Pressure Compensated

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