GE SENOGRAPHE 800T

GE Medical Systems SENOGRAPHE 800T
REV 6 om 2135575–100
vi
This product complies with the regulatory requirements of the following:
 Council Directive 93/42/EEC concerning medical devices when it bears the following
CE marking of conformity.
0459
For a system, the location of the CE marking label is described in the system manual.
European registered place of business:
GE Medical Systems Europe
Quality Assurance Manager
BP 34
F 78533 BUC CEDEX
France
Tel: +33 (0)1 30 70 40 40
 Green QSD 1990 Standard issued by MDD (Medical Devices Directorate, Department
of Health, UK).
 Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and
Drug Administration, Department of Health, USA).
 Underwriters’ Laboratories, Inc. (UL), an independent testing laboratory.
 Canadian Standards Association (CSA).
 International Electrotechnical Commission (IEC), international standards
organization, when applicable.
General Electric Medical Systems is ISO 9001 certified.