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

    BAXTER BAFFLED TEE ADAPTER

    K Number: K895014 · Decision Oct 30, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    167
    Registration Numbers
    167
    Same Product Code
    93
    Applicant Total
    505
    Review Days
    83

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    Basic Information

    Device Name
    BAXTER BAFFLED TEE ADAPTER
    K Number
    K895014
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5810
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Baxter Healthcare Corp
    Date Received
    August 8, 1989
    Decision Date
    October 30, 1989
    Product Code
    BZA
    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
    BZA Connector, Airway (Extension)

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