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510(k) Data Aggregation

    K Number
    K202483
    Device Name
    MyHomeDoc
    Manufacturer
    MyHomeDoc Ltd.
    Date Cleared
    2021-03-23

    (207 days)

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

    MyHomeDoc Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MyHomeDoc device, combined with a smartphone application, is a multiple-sensor device that is intended to measure, record, and transmit the recorded data of auscultation sound of human body, human body temperature, oxygen saturation (SpO2) and pulse rate, and images of an examined body part. MyHomeDoc device is intended for use by adult lay users in a non-clinical environment. MyHomeDoc application enables counseling with the physician and transmission of the information over an IP network.
    Device Description
    The MyHomeDoc device is a home use device is comprised of a handheld unit that connects with a smartphone and a dedicated smartphone software application that runs on the user's personal smartphone An API is defined to enable healthcare providers to communicate with the device. The Device enables user's examination at home with or without the guidance of a remote physician. It also enables guidance and data examination by a remote physician over an IP network. The Smartphone Application controls the Handheld Unit's functionality and processes and displays the collected data.
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