Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K193631
    Device Name
    Stethee Pro 1, Stethee Pro Software System
    Manufacturer
    M3DICINE Pty Ltd.
    Date Cleared
    2020-10-09

    (287 days)

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

    M3DICINE Pty Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stethee™ Pro 1 is an electronic stethoscope intended for screening and medical diagnostic purposes only. It may be used for the detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with or without the use of selective frequencies. It can be used on any person undergoing a physical assessment. Stethee Pro 1 is intended for use with the Stethee Pro Software System, whose features enable recording, playback, visualization, analysis, management and reporting of patient samples, and sharing this data with other authorized users.
    Device Description
    The Stethee Pro 1 is an electronic stethoscope intended for medical screening or diagnostic purposes only. Stethee Pro 1 may be used for detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with or without the use of selective filters. It can be used on any person undergoing a physical assessment. The Stethee Pro 1 consists of hardware and embedded software which controls all of the various features found in the device, such as sound capture, digital signal processing, volume control, haptic feedback for user, LED display ring, and wireless data transfer (via Bluetooth®). No patient data is stored on the Stethee Pro 1 device itself. After amplification and filtering of the sounds detected, Stethee Pro 1 transfers the sounds to the User's ears via any Bluetooth® connected headphones, or by wired headphones connected to Stethee Pro 1 using an AUX adaptor at the device's USB port. The Stethee Pro 1 also includes features that permit it to stream sounds to a peripheral smart device (e.g., mobile phone) as an audio buffer to a smart device (iOS or Android) via a Bluetooth® connection. The audio buffer is handled on the smart device by a separate standalone software application called the Stethee Pro Software System. Stethee Pro Software System (SPS) is a series of software applications (Stethee Pro Mobile Applications and the Stethee Pro Central Web Application) that work with the Stethee Pro 1 electronic stethoscope. Stethee Pro Software System is supported by M3DICINE's proprietary software platform M3DICINE Cloud Services (MCS) which provides various services including database, security, and core business logic services so that services for data sharing and multiple sign-ins from multiple devices can be implemented.
    Ask a Question

    Page 1 of 1