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

    BLEASE 6200 ANAESTHESIA VENTILATOR

    K Number: K982132 · Decision Apr 15, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    5
    Review Days
    302

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    Basic Information

    Device Name
    BLEASE 6200 ANAESTHESIA VENTILATOR
    K Number
    K982132
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Blease Medical Equipment , Ltd.
    Date Received
    June 17, 1998
    Decision Date
    April 15, 1999
    Product Code
    CBK
    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
    CBK Ventilator, Continuous, Facility Use

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    Other Clearances by Blease Medical Equipment , Ltd.

    K Number Device Name
    K041430 BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000
    K003251 BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690
    K001727 MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES
    K982137 BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE