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510(k) Data Aggregation

    K Number
    K212906
    Device Name
    HeartBuds Electronic Stethoscope
    Manufacturer
    Date Cleared
    2023-03-14

    (547 days)

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

    Heartbuds LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The HeartBuds Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location via the HeartBuds mobile application can listen to the auscultation sounds of a patient at a different location. The HeartBuds Stethoscope is intended to be used by professional users in a clinical environment or by non medical professional adult users in a non clinical environment. The device is for medical diagnostics purposes only. The device is not intended for self-diagnosis.
    Device Description
    HeartBuds is an electronic stethoscope intended to auscultate heart and lung sounds. HeartBuds Stethoscope can be used on any patient undergoing a physical assessment. This stethoscope consists of a hand-held device with integral plastic sound diaphragm, that must be used together with a smartphone equipped with the HeartBuds application software. HeartBuds Stethoscope allows users to digitally record heart and lung internal auscultation and transmit the sound data to a medical professional in another location. The HeartBuds system includes two (2) main components: The HeartBuds Electronic Stethoscope and the HeartBuds mobile app. The HeartBuds Electronic Stethoscope connects to mobile devices (Apple and Android) by means of an audio cable. The HeartBuds app with the integrated HeartBuds software provides users a platform to listen, display, and record sounds simultaneously using an external microphone. The users can share their recordings with their healthcare provider within the HeartBuds app for remote examination.
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