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

    MALLARD AIR OXYGEN ACCUBLENDER

    K Number: K001609 · Decision Aug 10, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    54
    Applicant Total
    2
    Review Days
    78

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    Basic Information

    Device Name
    MALLARD AIR OXYGEN ACCUBLENDER
    K Number
    K001609
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5330
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mallard Medical, Inc.
    Date Received
    May 24, 2000
    Decision Date
    August 10, 2000
    Product Code
    BZR
    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
    BZR Mixer, Breathing Gases, Anesthesia Inhalation

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    Other Clearances by Mallard Medical, Inc.

    K Number Device Name
    K033026 MALLARD MODEL 3000 ANESTHESIA MACHINE