An overview is given of IVAC Corporations' recent experience in getting FDA approval of the Titrator Sodium Nitroprusside Closed-Loop Module-Model 10K, which received FDA premarket approval on December 17, 1987. A chronology of events is presented. Guidelines for facilitating the process are offered
Published in:
Engineering of Computer-Based Medical Systems, 1988., Proceedings of the Symposium on the
Date of Conference: 8-10 Jun 1988