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

    BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000

    K Number: K041430 · Decision Oct 7, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    187
    Applicant Total
    5
    Review Days
    132

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    Basic Information

    Device Name
    BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000
    K Number
    K041430
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5160
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Blease Medical Equipment , Ltd.
    Date Received
    May 28, 2004
    Decision Date
    October 7, 2004
    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
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    K001727 MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES
    K982132 BLEASE 6200 ANAESTHESIA VENTILATOR
    K982137 BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE