BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    SULLIVAN NASAL CPAP SYSTEM

    K Number: K882292 · Decision Jun 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    72
    Same Product Code
    79
    Applicant Total
    1
    Review Days
    20

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    Basic Information

    Device Name
    SULLIVAN NASAL CPAP SYSTEM
    K Number
    K882292
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5965
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Baxter Centre For Medical Research
    Date Received
    June 1, 1988
    Decision Date
    June 21, 1988
    Product Code
    BYE
    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
    BYE Attachment, Breathing, Positive End Expiratory Pressure

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