HealthSTATS

Main information

  • Trade name:
  • HealthSTATS BPro Ambulatory Blood Pressure Monitoring System - Patient data recorder, long-term, sphygmomanometer
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • HealthSTATS BPro Ambulatory Blood Pressure Monitoring System - Patient data recorder, long-term, sphygmomanometer
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221446
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221446

HealthSTATS Australia - HealthSTATS BPro Ambulatory Blood Pressure Monitoring System - Patient data

recorder, long-term, sphygmomanometer

ARTG entry for

Medical Device Included Class IIa

Sponsor

HealthSTATS Australia

Postal Address

1312/576 St Kilda Road,MELBOURNE, VIC, 3004

Australia

ARTG Start Date

19/03/2014

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

HealthSTATS International Pte Ltd

6 New Industrial Road #04-01/02

Singapore, , 536199

Singapore

Products

1. HealthSTATS BPro Ambulatory Blood Pressure Monitoring System - Patient data recorder, long-term,

sphygmomanometer

Product Type

Medical device system

Effective date

19/03/2014

GMDN

36888 Patient data recorder, long-term, sphygmomanometer

Intended purpose

The BPro® ABPM system is intended for measuring systolic pressure, diastolic pressure and pulse rate

over a period of 24 hours at preprogrammed intervals. It is intended for use at home or in doctor's office

settings on patients who are eighteen (18) years or older, who have a palpable radial pulse, who do not

have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, and whose arm

circumferences are between 21 cm (8.3 in) and 42 cm (16.5 in). Blood pressure and pulse rate readings

obtained using the BPro are intended for use by qualified healthcare personnel as an aid to diagnosis and

treatment.

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 01:02:15 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