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510(k) Data Aggregation

    K Number
    K172296
    Device Name
    Stethee Pro
    Manufacturer
    M3dicine Pty. Ltd.
    Date Cleared
    2017-10-30

    (91 days)

    Product Code
    DQD
    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 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. It can be used on any person undergoing a physical assessment.
    Device Description
    The M3DICINE Stethee™ Pro 1 is an electronic stethoscope that picks up sounds of the heart, arteries, veins, lungs and other internal organs. Stethee™ Pro 1 provides capability for auscultation in frequencies from 20-2000Hz. After amplification and filtering, the sounds are transferred to the user's ears via any Bluetooth connected headphones. The Stethee™ Pro 1 includes features that permit it to record and store sounds on a peripheral smart device (e.g., mobile phone) by transferring the sounds as an audio buffer to the smart device via a Bluetooth® connection. The smart device makes use of a downloaded companion stand-alone Mobile Medical Application (MMA), Stethee™ App, to record, manage and replay the captured patient sounds on the smart device. Stethee™ App is also able to display the audio file as a phonocardiograph (21 CFR 870.2390) on the user's smart device and can use the audio file to calculate and display a simple Heart Rate. Stethee™ App does not direct or influence the performance of Stethee™ Pro 1. The Stethee™ Pro 1 device user interface includes a simple push down mechanism ("control knob") to start recording. It has a light-emitting diode (LED) display ring which indicates the device's status state (ON or OFF, charge status, and Bluetooth® synchronization status). The Stethee™ Pro 1 operates on a rechargeable certified 3.7V lithium ion polymer battery. The Stethee™ Pro 1 incorporates embedded software. The embedded software controls all the various features found in the Stethee™ Pro 1, such as sound capture, digital signal processing, volume control, LED display ring, and Bluetooth® transfer.
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