Device Dossier
Patient data recorder, long-term, electrocardiograph
Device Dossier for Patient data recorder, long-term, electrocardiograph (Patient data recorder, long-term, electrocardiograph, Class IIa, sponsor Sungo).…
- GMDN category: Patient data recorder, long-term, electrocardiograph
Intended purpose
Wearable DECG Recorder is intended to continuously measure, record, and periodically transmit cardiac rhythm and heart rate within specified duration in the professional healthcare environment and home-use environment. TER012: Specified duration: 120 hours EP-3: specified duration: 72 hours