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510(k) Data Aggregation

    K Number
    K191667
    Device Name
    Electronic Stethoscope
    Date Cleared
    2019-12-18

    (180 days)

    Product Code
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hefei Mintti Medical Technology Co., Ltd. China

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Electronic Stethoscope is intended for the detection and amplification of sounds from the heart, lungs and other internal organs with the use of a selective frequency. It can be used on any person undergoing a physical assessment for medical diagnostic purposes only.
    Device Description
    The Mintti Electronic Stethoscope, model smartho-D2 is a healthcare device that picks up sounds of the heart, lungs and other internal organs with the use of selective frequency ranges from 10-2000Hz. After amplification and filtering, the sounds are transferred to the user's ears via an wired-connected headset. The user interface includes a 5-button keypad and an 1.3' OLED display with a blue back-light. Sound processing is carried out with the aid of a digital signal processor. The smartho-D2 does not incorporate any off-the-shelf (OTS) software, and it incorporates embedded software which controls all the features of the product, including sound capture, digital signal processing, volume control, OLED display and Bluetooth function. The smartho-D2 operates on a certificated rechargeable 3.7V/2000mAh lithium ion battery.
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