
Regulatory Requirements
LOGIQ 500 Advanced Reference Manual
2276614–100 Rev. 0 Regulatory Req 1
Regulatory Requirements
This product complies with the regulatory requirements of the
following:
SCouncil Directive 93/42/EEC concerning medical devices:
the label affixed to the product testifies compliance
to the Directive.
The location of the CE marking is shown on 2–24 of this
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
SMedical Device Good Manufacturing Practice Manual
issued by the FDA (Food and Drug Administration,
Department of Health, USA).
SUnderwriters’ Laboratories, Inc. (UL), an independent
testing laboratory.
SCanadian Standards Association (CSA).
SInternational Electrotechnical Commission (IEC),
international standards organizations, when applicable.
Caution: United States law restricts this device to sale or use by
or on the order of a physician.
S
General Electric Medical Systems
is ISO 9001 and
EN 46001 certified.
SThe original document was written in English.
.For US
Only