Device Dossier

Incubator, infant, stationary

Device Dossier for Incubator, infant, stationary (Incubator, infant, stationary, Class IIb, sponsor GE Healthcare). ARTG record, intended purpose, GMDN…

Intended purpose

This is an electrically heated device which is intended to provide fixed temperatures and controlled incubation conditions that can be maintained providing an environment that imitates the natural conditions found in the mother's womb and is used for the treatment of premature and sick newborn babies. This incubator for newborn is intended to be used for stationary use, it has wheels but is generally kept within the ward/department to fulfill its purpose.

TGA Public Summary