Device Recall Innocor pulmonary function test device

  • Model / Serial
    Ref. INN00400, Serial no. 1551369, 1540362, 1540363, and 1536361.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, to Massachusetts and Washington, DC; and, the countries of Canada, Germany, and United Kingdom.
  • Product Description
    Innocor Cardiopulmonary Exercise and Lung Function Testing System || Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Innovision A/S, Skovvaenget 2, Glamsbjerg Denmark
  • Source
    USFDA