Hypoxicator, line-powered
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
19-07-2023
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Available from:
Regenerative Network Pty Ltd
Class:
Class IIb
Manufactured by:
Bitmos GmbH Himmelgeister Strasse 37, Dusseldorf, 40225 Germany
Therapeutic area:
46105 - Hypoxicator, line-powered
Therapeutic indications:
The ReOxy is intended for use for breathing related treatment of adults with two different oxygen gas mixtures that are alternatingly administered. The ReOxy produces alternatingly hypoxic and hyperoxic gas mixtures as per specification of the device. The intended therapeutic indication is the improvement of physical exercise capacity in adult and senior patients with Coronary Artery Disease (CAD). The unit may be used in the clinical environment under professional supervision only.
Authorization status:
A
Authorization date:
2023-05-03
