(27 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, convents that data into the HL7 external devices through device specific cables, oblivery and the comments of the System.
The provided text is a 510(k) summary for the M2376A Device Link System, a medical device intended for electronic data collection and clinical information management. The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the regulatory submission details, device description, intended use, and substantial equivalence determination.
Therefore, I cannot extract the requested information as it is not present in 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).