• DocumentCode
    1984879
  • Title

    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)

  • Author

    Paul, Albert

  • Author_Institution
    IVAC Corp., San Diego, CA, USA
  • fYear
    1988
  • fDate
    8-10 Jun 1988
  • Firstpage
    28
  • Lastpage
    29
  • Abstract
    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
  • Keywords
    medical computing; FDA approval; IVAC Corporations; Titrator Sodium Nitroprusside Closed-Loop Module; computer technology; medical device; Animals; Biomedical monitoring; Business; Computer industry; Control systems; Drugs; Food technology; Pharmaceutical technology; Servomechanisms; Testing;
  • fLanguage
    English
  • Publisher
    ieee
  • Conference_Titel
    Engineering of Computer-Based Medical Systems, 1988., Proceedings of the Symposium on the
  • Conference_Location
    Minneapolis, MN
  • Print_ISBN
    0-8186-4863-5
  • Type

    conf

  • DOI
    10.1109/ECBS.1988.5441
  • Filename
    5441
    • Link To Document
    https://search.isc.ac/dl/search/defaultta.aspx?DTC=49&DC=1984879