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

    IRNF App

    K Number: K212516 · Decision Oct 22, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    12
    Review Days
    73

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    Basic Information

    Device Name
    IRNF App
    K Number
    K212516
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2790
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Apple, Inc.
    Date Received
    August 10, 2021
    Decision Date
    October 22, 2021
    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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