Regulatory Requirements
LOGIQ 500 Basic Users Manual
2233658–100 Rev. 0
Regulatory Req 1
Regulatory Requirements
This product complies with the regulatory requirements of the
following:
S
Council 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 2–23 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
S
Medical Device Good Manufacturing Practice Manual
issued by the FDA (Food and Drug Administration,
Department of Health, USA).
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Underwriters’ Laboratories, Inc. (UL), an independent
testing laboratory.
S
Canadian Standards Association (CSA).
S
International 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.
S
The original document was written in English.
.
For USA
Only
Содержание Logiq 500
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