Single-patient physiologic monitoring system

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

Ixtrih issa

Disponibbli minn:
Quintessa Holdings Pty Ltd
Klassi:
Class IIa
L-istatus ta 'awtorizzazzjoni:
Included
Numru ta 'awtorizzazzjoni:
322628

Public Summary

Summary for ARTG Entry:

322628

Quintessa Holdings Pty Ltd - Single-patient physiologic monitoring system

ARTG entry for

Medical Device Included Class IIa

Sponsor

Quintessa Holdings Pty Ltd

Postal Address

Po Box 535,Heathmont, VIC, 3135

Australia

ARTG Start Date

3/09/2019

Product category

Medical Device Class IIa

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Biovotion AG

Kreuzstrasse 2

, Zurich, 8008

Switzerland

Products

1. Single-patient physiologic monitoring system

Product Type

Single Device Product

Effective date

3/09/2019

GMDN

33586 Single-patient physiologic monitoring system

Intended purpose

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.

Specific Conditions

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 02.11.2019 at 05:17:01 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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