LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K981378
    Device Name
    DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1
    Manufacturer
    DATEX-ENGSTROM, INC.
    Date Cleared
    1998-11-03

    (201 days)

    Product Code
    DRT
    Regulation Number
    870.2300
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1

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

    The Datex-Engstrom Light Monitor, F-LM1, F-LMP1 is for stationary and mobile monitoring of patient's ECG, SpO2, body temperature, invasive and non-invasive blood pressures as well as respiration and CO2 in hospitals and ambulances. When used outdoors, the monitor must be in the protective case.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for the Datex-Engstrom Light Monitor, F-LM1, F-LMP1. This document confirms the device is substantially equivalent to legally marketed predicate devices. However, it does not contain information about acceptance criteria, device performance, or any studies used to prove the device meets specific criteria.

    The letter focuses on the regulatory approval process and states the device's intended use and general controls provisions of the Act. It does not include the detailed technical or clinical study data that would be necessary to answer the questions about acceptance criteria and study design.

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

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1