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510(k) Data Aggregation

    K Number
    K162589
    Device Name
    Adscope 658 Electronic Stethoscope
    Manufacturer
    AMERICAN DIAGNOSTIC CORP.
    Date Cleared
    2017-03-10

    (175 days)

    Product Code
    DQD
    Regulation Number
    870.1875
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Adscope 658 Electronic Stethoscope

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Adscope® 658 Electronic Stethoscope is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung, and other body sounds. Frequency selection and volume buttons enable operator control. The 658 can be used on patients of any age undergoing a physical assessment. This device is designed for use in a professional setting by a healthcare practitioner.

    Device Description

    The Adscope® 658 Electronic Stethoscope is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung, and other body sounds. Frequency selection and volume buttons enable operator control.

    AI/ML Overview

    This 510(k) summary is for the Adscope® 658 Electronic Stethoscope and does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a clearance letter from the FDA stating that the device is substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot provide the requested information based on the provided text.

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