Sphygmomanometer

Main information

  • Trade name:
  • Sphygmomanometer, electronic, automatic-inflation, portable, arm/wrist
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Sphygmomanometer, electronic, automatic-inflation, portable, arm/wrist
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216483
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216483

Life Monitor Pty Ltd - Sphygmomanometer, electronic, automatic-inflation, portable, arm/wrist

ARTG entry for

Medical Device Included Class IIa

Sponsor

Life Monitor Pty Ltd

Postal Address

Suite 301 / 12 Cato Street,HAWTHORN EAST, VIC, 3123

Australia

ARTG Start Date

23/10/2013

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

Andon Health Co Ltd

No 3 Jinping Street YaAn Road

Tianjin, Nankai District, 300190

China

Products

1. Sphygmomanometer, electronic, automatic-inflation, portable, arm/wrist

Product Type

Single Device Product

Effective date

23/10/2013

GMDN

45617 Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Intended purpose

the device is a non-invasive pressure monitor intended for the measurement of systolic (SBP) and diastolic

(DBP) blood pressure and heart rate (HR or pulse rate) using oscillometric technique. It is used as an aid

to monitoring blood pressure in adults (individuals aged 18 and old) in a non-clinical environment such as

in the home. Results are displayed on the screen of the device.

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 05:02:12 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