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510(k) Data Aggregation

    K Number
    K982193
    Device Name
    ESOPHAGEAL STETHOSCOPE
    Manufacturer
    SHORE MEDICAL, INC.
    Date Cleared
    1998-09-01

    (71 days)

    Product Code
    BZT
    Regulation Number
    868.1920
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHORE MEDICAL, INC.

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

    The intended use of the esophageal stethoscope is to listen to heart and breath sounds while a patient is under anesthesia. Additionally, patient temperature can be monitored using the stethoscopes with 400 or 700 series thermistors. The stethoscopes are provided "packaged clean" and are for "single use" only.

    Device Description

    Esophageal Stethoscope

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for an "Esophageal Stethoscope." This document confirms the device's substantial equivalence to a legally marketed predicate device, allowing it to be marketed.

    However, the letter does not contain the specific information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    The document primarily focuses on the regulatory aspects of the device, such as its classification, general controls, and the process for marketing it. It states the "Indications for Use" which define what the device is intended for, but not how its performance was measured or validated.

    Therefore, I cannot provide the requested information from this document. It does not describe a study that proves the device meets acceptance criteria.

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