Device Dossier

Electrocardiograph, Holter analyser, software

Device Dossier for Electrocardiograph, Holter analyser, software (Electrocardiograph, Holter analyser, software, Class IIa, sponsor Philips Electronics).…

Intended purpose

Intended for use in a hospital or clinical setting, by trained personnel who are acting on the orders of a physician. The scanner evaluates the heartbeats of ambulatory patients recorded over an extended period. The final decision regarding the treatment of patients is the responsibility of the physician.

TGA Public Summary