BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    THE HAYEK OSCILLATOR

    K Number: K903745 · Decision Nov 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    20
    Applicant Total
    1
    Review Days
    85

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    Basic Information

    Device Name
    THE HAYEK OSCILLATOR
    K Number
    K903745
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5935
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Flexco Medical Instruments
    Date Received
    August 16, 1990
    Decision Date
    November 9, 1990
    Product Code
    BYT
    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
    BYT Ventilator, External Body, Negative Pressure, Adult (Cuirass)

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