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510(k) Data Aggregation

    K Number
    K220099
    Device Name
    eClinic Stethopod
    Manufacturer
    Date Cleared
    2022-10-20

    (281 days)

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

    HomeDiagnostic LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    eClinic Stethopod is an Electronic Stethoscope. It converts patient auscultation sound (heart, lungs, bowel, arteries, and veins) into audio signal and transmits it to clinically defined virtual appointment methods. It is intended to be used by professional users in a clinical environment or by lay users in a nonclinical or clinical environment to assist remote healthcare professionals' physical assessment. The device is not intended for self-diagnosis. eClinic Stethopod is intended for patients or customers who are 2 years and older. It is for both prescription use and over the counter use.
    Device Description
    eClinic Stethopod is an electronic stethoscope that is designed to be used with virtual communication systems for telehealth. It provides patient auscultation sounds for clinicians during virtual appointments while maintaining communication between clinicians and patients. The eClinic Stethopod is a passive electromechanical device. It converts physiological sounds into audio signals through a microphone. It further processes the signal through passive electronics for noise reduction and then transmits the real time data to clinically defined communication applications that connect patients and clinicians. eClinic Stethopod has a chest piece to pick up acoustic signal, a handle housing electronics that converts acoustic signal to audio signal and a cable to connect with communication devices. eClinic Stethopod needs to be connected to a communication device to achieve its intended use. There are two accessories: Apple ear pod and Apple adapter (lighting to 3.5 mm jack).
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