Respironics DreamStation BiPAP Systems - HSA Registration DE0501841
Access comprehensive regulatory information for Respironics DreamStation BiPAP Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0501841 and owned by Respironics, Inc. The device was registered on July 06, 2018.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The BiPAP S/T and AVAPS devices are intended to provide non-invasive ventilatory support to Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency patients weighing over 18 kg. This device may be used in the hospital or home. The BiPAP S/T and AVAPS devices are not intended for life support or invasive ventilation. The device provides Positive Pressure Ventilation and is indicated for assisted ventilation through a noninvasive interface. The device has the capability of providing a back-up rate as needed. The BiPAP S/T and AVAPS devices do not provide ventilation with a guaranteed tidal volume delivery. Patients requiring ventilation at a predetermined tidal volume are not candidates for Pressure Support ventilation.