Device Recall AVOXimeter 1000, AVOXimeter 4000

  • Modèle / numéro de série
    AVOXimeter 1000: K922075 AVOX1000, AVOX1000E-110, AVOX1000INT  AVOXimeter 4000: K951485 AVOX4000, AVOX4000D
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including TX, KS, OH, OR, FL, GA, NY, MA, and DC and the countries of Taiwan and Thailand
  • Description du dispositif
    AVOXimeter 1000, AVOXimeter 4000 || 1000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fraction, the total hemoglobin concentration, and oxygen content. It has enhanced software that optimizes its use int he cardiac catheterization laboratory through calculations of physiologic equations. 4000-a portable bedside whole blood CO-oximeter that directly measures total hemoglobin concentration and the relative concentrations of oxyhemoglobin carboxyhemoglobin concentration methemoglobin. In addition, oxygen content oxygen capacity and oxygen saturation indices are calculated.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    International Technidyne Corp., 68 Olsen Ave, Edison NJ 08820-2419
  • Société-mère du fabricant (2017)
  • Source
    USFDA