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

    Irregular Rhythm Notification Feature

    K Number: DEN180042 · Decision Sep 11, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    12
    Review Days
    33

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    Basic Information

    Device Name
    Irregular Rhythm Notification Feature
    K Number
    DEN180042
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    870.2790
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Apple, Inc.
    Date Received
    August 9, 2018
    Decision Date
    September 11, 2018
    Product Code
    QDB
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QDB Photoplethysmograph Analysis Software For Over-The-Counter Use

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