LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K051629
    Device Name
    BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000
    Manufacturer
    BLEASE USA, INC.
    Date Cleared
    2005-09-23

    (95 days)

    Product Code
    BSZ
    Regulation Number
    868.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    BLEASE USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Blease Frontline Sirius Range, Anaesthesia Machines are intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air, and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anaesthetic vapour by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.
    Device Description
    The Frontline Sirius with 8700 ventilator is similar to the cleared Frontline Sirius anaesthesia machine with the 6200 ventilator. The size and shape of the cabinet are identical, but the pneumatic systems are the same. The ventilator user interface is now graphical with colour LCD and Trak wheel control.
    Ask a Question

    Page 1 of 1