BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    AV-S ANAESTHESIA VENTILATOR

    K Number: K051222 · Decision Sep 23, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    3
    Review Days
    134

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    Basic Information

    Device Name
    AV-S ANAESTHESIA VENTILATOR
    K Number
    K051222
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Penlon Limited
    Date Received
    May 12, 2005
    Decision Date
    September 23, 2005
    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 Penlon Limited

    K Number Device Name
    K060331 SIGMA ALPHA VAPORIZER
    K053564 KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454