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510(k) Data Aggregation

    K Number
    K241086
    Device Name
    Avidhrt Sense SpO2
    Manufacturer
    Avidhrt Inc.
    Date Cleared
    2025-05-09

    (385 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Avidhrt Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Avidhrt Sense is a handheld spot-checking measurement device, indicated to do the following: • Non-invasive spot checking of functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse waveform (when prescribed by a physician). Avidhrt Sense SpO2 is intended for use in adult patients in the home environment. The Avidhrt Sense SpO2 is not for continuous monitoring, use during motion or for patients with low perfusion. The Avidhrt Sense SpO2 is not intended for pediatric use.
    Device Description
    Avidhrt Sense SpO2 is a handheld spot-checking measurement device designed for non-invasive spot checking of functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse waveform (when prescribed by a physician). Avidhrt Sense SpO2 is used in conjunction Avidhrt Sense SpO2 smart phone app that displays the SpO2.
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