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The travail involved in getting FDA approval . . . an overview on what it took to get FDA approval of a medical device with computer technology (A recent experience)

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1 Author(s)
Paul, A. ; IVAC Corp., San Diego, CA, USA

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