Device Dossier
Interpretive multichannel electrocardiograph
Device Dossier for Interpretive multichannel electrocardiograph (Interpretive multichannel electrocardiograph, Class IIa, sponsor Intermed Medical). ARTG…
- GMDN category: Interpretive multichannel electrocardiograph
- Sponsor: Intermed Medical
Intended purpose
The CARDIOVIT FT-2 is an electrocardiograph device intended to be used by or under the direct supervision of a licensed physician in healthcare facilities to acquire ECG signals from body surface electrodes, record, analyse, display and print ECGs to support diagnosis in adult and paediatric patients at rest. The spirometry option is intended to record, analyse, display and print measurements and waveforms of pulmonary function tests to support diagnosis in adult and paediatric patients.