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

    BABYFLEX HEATED INFANT BREATHING CIRCUIT

    K Number: K896365 · Decision Jan 22, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    199
    Registration Numbers
    199
    Same Product Code
    183
    Applicant Total
    505
    Review Days
    77

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    Basic Information

    Device Name
    BABYFLEX HEATED INFANT BREATHING CIRCUIT
    K Number
    K896365
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5240
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Baxter Healthcare Corp
    Date Received
    November 6, 1989
    Decision Date
    January 22, 1990
    Product Code
    CAI
    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
    CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)

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