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

    Loss of Pulse Detection

    K Number: K242967 · Decision Feb 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    152

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    Basic Information

    Device Name
    Loss of Pulse Detection
    K Number
    K242967
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2790
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fitbit
    Date Received
    September 26, 2024
    Decision Date
    February 25, 2025
    Product Code
    SDY
    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
    SDY Loss Of Pulse Notification Software