Fisher & Paykel Healthcare ICON CPAP

  • Modèle / numéro de série
    Lot 121210: December 10th, 2012. Lot 121221: December 21st, 2012.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.
  • Description du dispositif
    Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). || Models: || ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. || ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ. || ICON Premo: ICONPBN, ICONPBN-HT, ICONPBN-HTC. || The ICON CPAP unit is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory. The device is not intended to be used as a life supporting device.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Fisher & Paykel Healthcare, Ltd., 15 Marcel Place, East Tamaki, North Shore City New Zealand
  • Source
    USFDA