(201 days)
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.
Not Found
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.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).