Search Results
Found 1 results
510(k) Data Aggregation
K Number
K210736Device Name
doctorgram Stethoscope DES-I
Manufacturer
Date Cleared
2021-07-27
(138 days)
Product Code
Regulation Number
870.1875Why did this record match?
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.
Ask a Question
Ask a specific question about this device
Page 1 of 1