Computer, cardiac catheterization laboratory

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Class:
Class IIb
Authorization status:
Included
Authorization number:
322123

Public Summary

Summary for ARTG Entry:

322123

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Computer, cardiac catheterization laboratory

ARTG entry for

Medical Device Included Class IIb

Sponsor

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Postal Address

Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000

Australia

ARTG Start Date

21/08/2019

Product category

Medical Device Class IIb

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

Change Healthcare Canada Company

10711 Cambie Road

Richmond, BC, V6X 3G5

Canada

Products

1. Computer, cardiac catheterization laboratory

Product Type

Single Device Product

Effective date

21/08/2019

GMDN

10980 Computer, cardiac catheterization laboratory

Intended purpose

The device is intended for complete physiological/ hemodynamic monitoring, clinical data acquisition,

medical image and data processing, and analytical assessment. The device is also intended for

patient/procedural data management, such as documentation, logging, reporting, trending, storing,

reviewing, carrying out clinical calculations and exporting various representations of the acquired data.

Data may also be acquired from and/or sent to other devices, such as physiological monitoring systems,

information management systems, image acquisition/storage devices, and other medical devices. The

device is intended for use in the areas of: cardiology, cardiac catheterization, electrophysiology, radiology,

invasive radiology, and other areas where patient/procedural data management is needed.

User-adjustable alarms (both visual and audible) available in the system alert the operator to anomalous

occurrences and facilitate timely responses. Use of the system is not intended for unattended patient

monitoring or in situations where arrhythmia detection is required.

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 06:21:23 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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