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510(k) Data Aggregation

    K Number
    K060321
    Device Name
    ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK
    Manufacturer
    AMERICAN DIAGNOSTIC CORP.
    Date Cleared
    2006-05-15

    (95 days)

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

    ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK

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

    The ADSCOPE 657BK Electronic Stethoscope is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung, and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a conventional electronic stethoscope. It does not contain information about acceptance criteria or a study proving device performance as it is not an AI/ML device.

    Therefore, I cannot provide the requested information based on the given input.

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