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

    Body Temperature Software (BTS)

    K Number: K243778 · Decision Feb 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    66

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    Basic Information

    Device Name
    Body Temperature Software (BTS)
    K Number
    K243778
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.2915
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fitbit, LLC
    Date Received
    December 9, 2024
    Decision Date
    February 13, 2025
    Product Code
    QZA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QZA Body Temperature Sensing Software

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QZA), ordered by most recent decision date.

    Body Temperature Software (BTS)

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Fitbit, LLC

    K Number Device Name
    DEN230050 Body Temperature Software (BTS)