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The VISICU ARGUS System is intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks.

The VISICU ARGUS System is intended to provide patient information and surveillance of monitored patients at the point of care location and at a remote supplementary care location through wide area networking technology and dedicated telephone lines.

The VISICU ARGUS System is solely intended for use in a hospital environment. It is not intended to be used in a home environment.

Not Found

This document is a 510(k) clearance letter from the FDA for the VISICU Argus System, dated July 24, 2001. It indicates that the device has been found substantially equivalent to a legally marketed predicate device. However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Therefore, I cannot provide the requested table and study details from the given text.

The document primarily focuses on:

• The FDA's decision to clear the device for marketing.
• The device's regulation number, class, and product code.
• The intended indications for use of the VISICU ARGUS System, which include data collection, storage, clinical information management, and patient information/surveillance at point of care and remote locations within a hospital environment.

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