PRO-Diary User Guide 1.2.1 10/02/15
Page
2
PRO-Diary Motion Regulatory Information
Medical Device Directive
(European Union)
The PRO-Diary Motion is a Class I Medical Device conforming to the essential safety
& health requirements and provisions of EC
Council Directives 93/42/EEC, Annex
VII. An EC declaration of Conformity will be provided upon request.
US FDA status
The PRO-Diary is FDA cleared for prescription use only with FDA 510(k) number
K132764
.
Manufacturer:
CamNtech Ltd
Upper Pendrill Court
Papworth Everard
Cambridgeshire
CB23 3UY, UK
Tel: 01480 831223
Fax: 01480 831733
Email:
Australian Sponsor:
Please note that the sponsor should be contacted ONLY to report adverse events
–
all sales and support issues must be directed to CamNtech in the UK.
Emergo Australia
Level 20
Tower II, Darling Park
201 Sussex Street
Sydney, NSW 2000
Australia
Applicable Standards:
The appropriate clauses of the following standards have been used as a means of
demonstrating compliance.
Standard
Description
EN60601-1:2006
Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance.
EN60601-1-2:2007
Medical electrical equipment – Part 1-2: Collateral standard:
Electromagnetic compatibility – Requirements and tests.
See Appendix C for declaration and guidance
EN60601-1-11:2010
Medical electrical equipment – Part 1-11: Collateral standard:
Requirements for medical electrical equipment and medical electrical
systems used in the home healthcare environment.
EN60601-1-6:2010
Medical electrical equipment – Part 1-11: Collateral standard: Usability
EN62304:2006
Medical device software – Software life-cycle processes
