Single-patient physiologic monitoring system

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

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PAR PAR (PAR)
01-11-2019

MAH:

Quintessa Holdings Pty Ltd

class:

Class IIa

manufactured_by:

Biovotion AG Kreuzstrasse 2, Zurich, 8008 Switzerland

therapeutic_area:

33586 - Single-patient physiologic monitoring system

therapeutic_indication:

Everion CD / Everion MD is a wearable device which monitors the vital signs of a patient in either a clinical setting or in a home care setting. This data can be used by the physician to determine the health status of the patient. The Everion CD / Everion MD is not intended for continuous monitoring of life-threatening situations. It does not warn the patient or physician in case of acute, life-threatening health situations. The Everion is used by an individual patient. The patient shall be at least 18 years old and capable to handle the Everion CD / Everion MD by him- or herself.

authorization_status:

A

authorization_date:

2019-09-03