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

    MODEL 90 BC

    K Number: K821415 · Decision May 27, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    7
    Review Days
    15

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    Basic Information

    Device Name
    MODEL 90 BC
    K Number
    K821415
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Western Laboratories Corp.
    Date Received
    May 12, 1982
    Decision Date
    May 27, 1982
    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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