(8 days)
The M2376A DeviceLink System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices.
The M2376A is not intended for monitoring purposes, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.
The M2376A Device Link System receives digital data produced by external devices through device specific cables, converts that data into the HL7 External us noos through anformation to any networked Clinical Information System.
When connected to a bedside device, the M2376A Device Link System is intended for electronic data collection and clinical information management. is intended for olocionis data collected, nor does it remotely control the attached source device.
This is a 510(k) summary for a medical device called the M2376A Device Link System. This document does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria. It focuses on the regulatory submission, classification, and intended use of the device.
Therefore, I cannot provide the requested information from the provided text.
§ 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).