LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K050785
    Device Name
    AMSINO ENDOTRACHEAL TUBE
    Manufacturer
    AMSINO INTERNATIONAL, INC.
    Date Cleared
    2005-07-15

    (109 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AMSINO ® Endotracheal Tube is intended for use in airway management by oral/nasal intubation of the trachea. The cuff inflation system (where applicable) is used to establish a seal between the tube and the trachea.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA to Amsino International, Inc. regarding their AMSINO™ Endotracheal Tube. It states that the device is substantially equivalent to legally marketed predicate devices.

    The document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, or specific study types (MRMC or standalone). This type of detailed performance data is typically found in the 510(k) submission itself, not in the FDA's decision letter.

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

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1