Finapres

Main information

  • Trade name:
  • Finapres Nova - Patient monitoring system module, blood pressure, noninvasive
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Finapres Nova - Patient monitoring system module, blood pressure, noninvasive
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216787
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216787

Pacing Importers Pty Ltd - Finapres Nova - Patient monitoring system module, blood pressure, noninvasive

ARTG entry for

Medical Device Included Class IIa

Sponsor

Pacing Importers Pty Ltd

Postal Address

8-12 Alma Road,ST KILDA, VIC, 3182

Australia

ARTG Start Date

31/10/2013

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

FMS Finapres Medical Systems BV

Hogehilweg 8

Amsterdam, , 1101 CC

Netherlands

Products

1. Finapres Nova - Patient monitoring system module, blood pressure, noninvasive

Product Type

Medical device system

Effective date

31/10/2013

GMDN

36551 Patient monitoring system module, blood pressure, noninvasive

Intended purpose

The Finapres Nova is a standalone device intended for desktop use. Measurements are to be performed

under uninterrupted patient surveillance of the operator.

The Finapres Nova is used in a professional medical environment (i.e. hospitals, clinics and research

institutions etc.). The Finapres Nova is suitable for use in an operating room in the non-sterile zone.

Specific Conditions

No Specific Conditions included on Record

© 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 10.11.2017 at 04:18:19 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