Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Computer, cardiac catheterization laboratory
ARTG entry for
Medical Device Included Class IIb
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000
ARTG Start Date
Medical Device Class IIb
- 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.
Change Healthcare Canada Company
10711 Cambie Road
Richmond, BC, V6X 3G5
1. Computer, cardiac catheterization laboratory
Single Device Product
10980 Computer, cardiac catheterization laboratory
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.
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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.
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