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

    BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690

    K Number: K003251 · Decision May 23, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    187
    Applicant Total
    5
    Review Days
    218

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    Basic Information

    Device Name
    BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690
    K Number
    K003251
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5160
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Blease Medical Equipment , Ltd.
    Date Received
    October 17, 2000
    Decision Date
    May 23, 2001
    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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    Other Clearances by Blease Medical Equipment , Ltd.

    K Number Device Name
    K041430 BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000
    K001727 MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES
    K982132 BLEASE 6200 ANAESTHESIA VENTILATOR
    K982137 BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE