News | May 27, 2007

Docusys Achieves New FDA Standard for Anesthesia IT

May 29, 2007 — Following a stringent review process, DocuSys, Inc., a provider of Anesthesia Information Management Systems (AIMS) and Digital Drug Management Systems, has received 510(k) clearance from the FDA to market its technology and is now a registered medical device manufacturer in accordance with FDA guidelines.

Specific medical devices, as identified by the FDA, require 510(k) clearance in order to market them in the U.S. and in a recent decision by the FDA, AIMS systems have been added to the list of products that require this clearance. Implicit in conforming to FDA regulations is compliance with Quality System Regulations (QSRs), Current Good Manufacturing Practices (CGMPs) and other applicable Code of Federal Regulations (CFR) practices.

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