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

    BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS

    K Number: K901548 · Decision Jan 14, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    14
    Applicant Total
    174
    Review Days
    286

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    Basic Information

    Device Name
    BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS
    K Number
    K901548
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Shiley, Inc.
    Date Received
    April 3, 1990
    Decision Date
    January 14, 1991
    Product Code
    CCC
    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
    CCC Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling

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