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The M2376A DeviceLink System is indicated for use in data collection and 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 and transmits that information to any networked Clinical Information System.

The provided text is a 510(k) summary for the M2376A Device Link System, a device intended for electronic data collection and clinical information management. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Identification of the submitter and device.
• Description of the device's function: receiving digital data from external devices, converting it to HL7 External, and transmitting it to a networked Clinical Information System.
• Intended Use statement: for data collection and clinical information management from bedside devices, explicitly stating it's not for monitoring or controlling attached devices.
• FDA's decision letter: confirming substantial equivalence to a legally marketed predicate device.

Therefore, I cannot provide a response to your request, as the necessary information is not present in the provided text.

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