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510(k) Data Aggregation

    K Number
    K201299
    Device Name
    HD Steth
    Manufacturer
    HD Medical, Inc.
    Date Cleared
    2020-07-10

    (56 days)

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

    HD Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HD Steth is an electronic stethoscope meant to assist a qualified clinician to capture, record and replay heart sounds and electrocardiogram (ECG or EKG) rhythm. It is intended to be used on one patient at a time. Heart sounds (PCG) and 1-lead EKG rhythm are acquired and displayed simultaneously on an accompanying mobile application on a hand-held smart device like a phone or tablet. The waveforms can be recorded and saved on the smart device on which the app is running. The device has 3 auscultation modes – Bell, Diaphragm and Lung (Wide). These modes and volume levels can be changed by the press of a button. The EKG rhythm recording assists in getting an indicative Heart Rate (HR) that gets displayed on a display panel on the device. The device must be used in a clinical setting by trained and qualified personnel only. HD Steth is not intended to be used as a diagnostic device. It does not supersede the judgement of a qualified clinician. The device is intended to aid the physician in the evaluation of PCG and EKG rhythm. The clinicians are completely responsible for reviewing and interpreting the results, along with all other relevant information, when making a referral decision. Caution: The sale of this device is restricted to licensed clinicians or entities referred to by a licensed clinician. It is intended for use by a licensed clinician only.
    Device Description
    HD Steth is an electronic audio-visual stethoscope with integrated electrodes for electrocardiogram (ECG or EKG) rhythm. HD Steth is designed to acquire heart sounds through a diaphragm and 1-lead EKG rhythm through three fixed electrodes integrated around the diaphragm. The device has 3 auscultation modes – Bell, Diaphragmand Lung (Wide). The EK G rhythm recording assists in getting an indicative Heart Rate (HR) that gets displayed on a display panel on the device. Both the heart sounds or phonocardiogram (PCG) and the EKG rhythm are acquired simultaneously and can be visualized, recorded and replayed using an accompanying mobile application. HD Steth provides high fidelity audio in addition to visually observing a PCG and ECG Rhythm signal.
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