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510(k) Data Aggregation

    K Number
    DEN220048
    Device Name
    Neoasis
    Date Cleared
    2023-06-16

    (326 days)

    Product Code
    Regulation Number
    880.5405
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Neoasis® device is intended to reduce noise levels inside an infant incubator in the neonatal intensive care unit (NICU). The attenuation performance of the device is for noises in the NICU with frequencies between 250 Hz to 1,000 Hz.
    Device Description
    The Neoasis is comprised of an outside noise sensor, a control unit, two speakers, and a residual noise sensor. All components are connected to the control unit with different cables. The outside noise sensor captures the environmental noise and transmits the information to the control unit. The control unit determines if the noise should be attenuated and contains a software algorithm which calculates the sound wave necessary to cancel out the environmental noise. If cancelation is appropriate, the control unit plays the corresponding sound wave through the speakers inside of the incubator, attenuating the noise via deconstructive interference. The residual noise sensor then captures the resulting noise inside of the incubator and communicates it to the control unit. Additionally, the device contains a voice pass through feature which allows parents or healthcare practitioners to communicate with the infant from the outside using the control unit and speakers.
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