BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    COMPANION 318 NASAL CPAP SYSTEM

    K Number: K903764 · Decision Sep 10, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    72
    Same Product Code
    79
    Applicant Total
    110
    Review Days
    21

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    Basic Information

    Device Name
    COMPANION 318 NASAL CPAP SYSTEM
    K Number
    K903764
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5965
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Puritan Bennett Corp.
    Date Received
    August 20, 1990
    Decision Date
    September 10, 1990
    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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