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

    PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT

    K Number: K912428 · Decision Aug 9, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    9
    Applicant Total
    110
    Review Days
    70

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    Basic Information

    Device Name
    PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT
    K Number
    K912428
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1170
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Puritan Bennett Corp.
    Date Received
    May 31, 1991
    Decision Date
    August 9, 1991
    Product Code
    CBZ
    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
    CBZ Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling

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