Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Biotronik Australia Pty Ltd - Cardiac mapping system workstation
ARTG entry for
Medical Device Included Class IIb
Biotronik Australia Pty Ltd
Suite 2 Level 4 Building 2,20 Bridge Street,PYMBLE, NSW, 2073
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.
Acutus Medical Inc
2210 Faraday Avenue Suite 100
, Carlsbad, 92008
United States Of America
1. Cardiac mapping system workstation
Single Device Product
31742 Cardiac mapping system workstation
The console connects to the different elements of an EP mapping system to format and transmit signals to
the computer for display and analysis. It contains all electronics for interfacing with patient-contacting
devices required by the system. It also provides patient isolation, signal filtering, signal digitization, and
transmission of ultrasound and localization signals. The Console includes an internal auxiliary power
supply to provide clinical grade ECG output signals in the event of a power outage or other disruption of
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Produced at 02.11.2019 at 03:48:50 AEDT
This is not an ARTG Certificate document.
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