BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    CAREVENT CA AND DRA

    K Number: K051889 · Decision Aug 30, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    99
    Applicant Total
    7
    Review Days
    49

    Basic Information

    Device Name
    CAREVENT CA AND DRA
    K Number
    K051889
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5925
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    O-TWO MEDICAL TECHNOLOGIES, INC.
    Date Received
    July 12, 2005
    Decision Date
    August 30, 2005
    Product Code
    BTL
    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
    BTL Ventilator, Emergency, Powered (Resuscitator)

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    Other Clearances by O-TWO MEDICAL TECHNOLOGIES, INC.

    K Number Device Name
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