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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES

    K Number: K122610 · Decision Aug 5, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    72
    Same Product Code
    79
    Applicant Total
    1
    Review Days
    343

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    Basic Information

    Device Name
    PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES
    K Number
    K122610
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5965
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sen MU Technology Co., Ltd.
    Date Received
    August 27, 2012
    Decision Date
    August 5, 2013
    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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