HSA · registration DE0019108Respironics Alice NightOne
- Registration number
- DE0019108
- Model name
- Reusable Finger Sensor (Soft), Large; Reusable Finger Sensor (Soft), Medium; Reusable Finger Sensor (Soft), Small; Sleepware G3 Software V3.9.2; Alice NightOne Durabelt, Adult; Alice NightOne Durabelt, Large; Alice NightOne System, Wireless, Intl; Alice NightOne System, Intl; Alice NightOne Nonin SpO2 Cable; Reusable Finger Sensor; Finger Flex Oximeter Sensor, Adult; Pro-Flow, Nasal Cannula, Adult, 16' (40.64cm); Pro-Flow Plus Nasal Oral Cannula, Adult, 16' (40.64cm); Pro-Flow, Nasal Cannula, Adult, 16' (40.64cm)
- Model identifier
- 1062049; 1062050; 1062051; 1082462; 1113310; 1113311; 1114801; 1114803; 1119823; 936; 953; P1328-60; P1343; P1390
- Registration date
- March 29, 2017
- Source update date
- August 07, 2020
- Risk class
- Class B
- Product owner
- Respironics, Inc.
- Registrant / registration holder
- PHILIPS ELECTRONICS SINGAPORE PTE LTD
Alice NightOne is a physiological data recorder intended to collect and record data from multiple physiological channels. It is intended for use by or on the order of a physician. The Alice NightOne is intended for use in a supervised (hospital) or unsupervised (home) environment. Alice NightOne is intended as a diagnostic device for adults. No physiological alarms are present. Alice NightOne is not a monitor.
- Product owner address
- 1001 Murry Ridge Lane, Murrysville, PA 15668, United States
- Registrant address
- 622 LORONG 1 TOA PAYOH, Singapore 319763
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.