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REGULATORY

QUALITY POLICY

ivWatch’s mission is to create high quality sensor technology and exceed customer expectations under a compliant and effective Quality Management System; to provide continuous monitoring and eliminate patient harm associated with IV infiltrations and extravasations.

–Gary Warren, President & CEO, ivWatch

Quality/Regulatory Clearances and Certificates

FDA 510(k) Clearance February 2015 – View PDF

FDA 510(k) Clearance February 2016 – View PDF

FDA 510(k) Clearance December 2016 – View PDF

ISO 13485: 2016 Certification – View PDF

Canada Medical License – View PDF

CE Marking – View PDF

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Thank you for requesting more information about the ivWatch Clinical Studies. The ivWatch Model 400 is the only continuous monitoring device for the early detection of IV infiltration and extravasation events.

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