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510(k) Data Aggregation

    K Number
    K230613
    Device Name
    SKEEPER
    Manufacturer
    Smartsound Corporation
    Date Cleared
    2023-08-02

    (149 days)

    Product Code
    DQD, DOD
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    Smartsound Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SKEEPER is an electronic stethoscope that collects, fitters, and amplifies the sound of a person's heart, lungs, and abdomen. It is intended for use by professional users in clinical environments or by lay users in non-clinical environments. It is not intended for self-diagnosis.
    Device Description
    SKEEPER is an electronic stethoscope used to collect and measure the sounds inside the body, and it consists of an electronic stethoscope (SM-300) and a mobile application (SKEEPER PRO APP). When the diaphragm at the bottom of the SM-300 is lightly attached to the body part to be measured, such as the heart, lungs, or abdomen, the diaphragm vibrates due to the sound inside the human body and generates a sound. This sound is collected using a microphone and converted into an electrical signal. After that, the electrical signal is filtered and amplified for each frequency band set according to the measurement site, amplified, and output to earphones or transmitted to the SKEEPER APP installed on the mobile platform, and then the sound is output the earphone or speaker of the corresponding platform. The SKEEPER PRO APP graphs the waveform of the sound received by the SM-300. It also stores and plays back sound data and analyzes heart rate.
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