HSA · registration DE0501088Respironics Dorma 500 Auto System
SingaporeGeneral HospitalClass BRespironics, Inc.
Official record identity
- Registration number
- DE0501088
- Model name
- Performance tubing, 6' (1.83m), White; System One Heated Humidifier INT; Dorma 500 Auto, INTL; Dorma 500 Auto, w/ Humid, INTL
- Model identifier
- 1032907; IN6H; INV501; INV501H
- Registration date
- January 12, 2018
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Respironics, Inc.
- Registrant / registration holder
- PHILIPS ELECTRONICS SINGAPORE PTE LTD
Official description
The Philips Respironics Dorma 500 Auto system delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30 kg (66 lbs). It is for use in the home or hospital/institutional environment.
Additional source fields
- Product owner address
- 1001 Murry Ridge Lane, Murrysville, PA 15668, United States
- Registrant address
- 622 LORONG 1 TOA PAYOH, Singapore 319763
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.