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510(k) Data Aggregation

    K Number
    K210736
    Device Name
    doctorgram Stethoscope DES-I
    Manufacturer
    Date Cleared
    2021-07-27

    (138 days)

    Product Code
    Regulation Number
    870.1875
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    Applicant Name (Manufacturer) :

    GV Concepts

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The doctorgram™ Stethoscope DES-I is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data (heart, lungs, bowel, arteries, and veins), whereby a clinician at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. The doctorgram™ Stethoscope DES-I is intended for use on pediatric and adult patients. The doctorgram™ Stethoscope DES-I is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis.
    Device Description
    The doctorgram™ Stethoscope DES-I (hereafter referred to as DES-I stethoscope) is a digital stethoscope device designed for use by health care professionals as well as lay users in clinical or non-clinical environments. It can electronically amplify, filter and transfer sounds to the accompanying mobile application for storage and sharing or can transmit the data for telemedicine use. It also enables regular users to listen to their body sounds (lungs, heart, arteries, veins, Gastrointestinal tract, etc.) and record and share it with their physicians. It consists of two primary components: 1) The DES-I stethoscope handheld piece, a stand-alone electronic stethoscope and 2) Doctor's Ear, a mobile application that pairs with the Doctorgram Stethoscope.
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