Device Dossier
Chamber, patient, hyperbaric
Device Dossier for Chamber, patient, hyperbaric (Chamber, patient, hyperbaric, Class IIb, sponsor Luke Whelan). ARTG record, intended purpose, GMDN…
- GMDN category: Chamber, patient, hyperbaric
Intended purpose
The intended use of the TEKNA® Modular Rectangular Hyperbaric Oxygen Therapy Chamber Product Family is to administer near 100% oxygen at pressures greater than ambient pressure, up to 3 ATA (Atmospheres Absolute). The entire patient should be exposed to a pressure of up to 3 Atmosphere while breathing medical grade oxygen.