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The Datex-Engstrom Network transfers information between networked Datex-Engstrom devices. It allows a networked device to display, store, print and otherwise process information received from other networked devices.

The Datex-Engstrom Information Centre maintains the network connections between the Datex-Engstrom bedside monitors and other networked devices in Datex-Engstrom Network. Furthermore, it coordinates the transfer of information between devices in the Datex-Engstrom Network as well as between the Datex-Engstrom Network and Hospital Information Systems (HIS).

The Datex-Engstrom Information Centre can be used for storing, printing, viewing or otherwise processing of information from several bedside monitors or other networked devices.

The Datex-Engstrom Network will be used for patients in the hospital and it is meant for continuous use.

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Unfortunately, the provided document is a 510(k) clearance letter for the Datex-Engstrom Network, a device for transferring information between networked medical devices. This document does not contain any information about acceptance criteria, device performance studies, or clinical trial data.

The letter primarily focuses on the FDA's determination of substantial equivalence for the device based on its intended use as described by the manufacturer. It confirms that the device can be legally marketed, subject to general controls and potentially special controls for its regulatory class.

Therefore, I cannot answer your specific questions related to acceptance criteria and performance studies because that information is not present in the provided text. To answer those questions, you would need access to the actual 510(k) submission or related technical documentation, which would detail the performance testing and validation results for the Datex-Engstrom Network.

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