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

    COBE RX METER

    K Number: K830629 · Decision Apr 6, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    77
    Review Days
    36

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    Basic Information

    Device Name
    COBE RX METER
    K Number
    K830629
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Cobe Laboratories, Inc.
    Date Received
    March 1, 1983
    Decision Date
    April 6, 1983
    Product Code
    FLB
    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
    FLB Meter, Conductivity, Induction, Remote Type

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