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

    NUFFIELD ANESTHESIA VENTILATOR SER. 400

    K Number: K803052 · Decision Jan 7, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    187
    Applicant Total
    10
    Review Days
    36

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    Basic Information

    Device Name
    NUFFIELD ANESTHESIA VENTILATOR SER. 400
    K Number
    K803052
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5160
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Penlon, Inc.
    Date Received
    December 2, 1980
    Decision Date
    January 7, 1981
    Product Code
    BSZ
    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
    BSZ Gas-Machine, Anesthesia

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