Device Dossier

CPAP/BiPAP face mask, reusable

Device Dossier for CPAP/BiPAP face mask, reusable (CPAP/BiPAP face mask, reusable, Class IIa, sponsor Fisher & Paykel Healthcare). ARTG record, intended…

Intended purpose

The Full Face Mask is intended for multiple patient and single patient use by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level ventilator treatment in the home, hospital or other clinical setting.

TGA Public Summary