LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K022298
    Device Name
    I-STETHOS LINK
    Manufacturer
    ANDROMED, INC.
    Date Cleared
    2002-10-01

    (77 days)

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

    I-STETHOS LINK

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

    The i-Stethos Link Electronic Stethoscope is intended for the purpose of electronically amplifying and listening to biological sounds, such as those produced by the heart, lungs, arteries and veins, and other internal organs and systems. The i-Stethos Link may also be used to display the heart rate, which is calculated as the number of heartbeats per minute.

    In addition, the i-Stethos Link is equipped with an analog I/O port to interface with external devices such as a computer and to accept input from other compatible devices such as the biological sound monitor (BSM) sensor or another i-Stethos Link.

    The i-Stethos Link Electronic Stethoscope is indicated for use under the same conditions that would otherwise require the use of an acoustic (non-electronic) stethoscope.

    The i-Stethos Link Electronic Stethoscope is not intended as a substitute for medical care or for diagnosis and treatment by unlicensed or unqualified persons.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter for the i-Stethos Link Electronic Stethoscope. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain information about specific performance acceptance criteria, detailed study designs, or results from such studies (like multi-reader multi-case studies, standalone performance, training sets, or adjudication methods). It is primarily a regulatory clearance document.

    Therefore, I cannot provide the requested information from the given text.

    The document does not include:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes used for the test set or data provenance.
    • Number and qualifications of experts for ground truth.
    • Adjudication method for the test set.
    • Results from a multi-reader multi-case comparative effectiveness study.
    • Standalone performance data.
    • Type of ground truth used (e.g., pathology, outcomes data).
    • Sample size for the training set.
    • How ground truth for the training set was established.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1