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 GE…
- GMDN category: Patient data recorder, long-term, electrocardiograph
- Sponsor: GE Healthcare
Intended purpose
This device is intended to continuously record up to 48 hours of ECG data on a digital flash memory card. The device performs no cardiac analysis by itself and is intended to be used with analysis software. The recorded data are downloaded to a PC for analysis and following evaluation by a trained physician or health care professional.