GE LOGIQ A100 Technical Publication page 5

Regulatory Requirement
1.
Council Directive 93/42/EEC concerning medical devices; the
label affixed to the product testifies compliance to the Directive.
The location of the CE label is documented on page 56.
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
2. 510k approval for FDA (Food and Drug Administration) registration,
Department of Health, USA.
3. ETL (Electronics Testing Laboratory) certificate by ITS, based on
UL 2601–1.
4. MHW (Ministry of Health and Welfare) registration for Japan.
CAUTION
United States Federal law restricts this device
to use by or on the order of a physician.
5. General Electric Medical Systems is ISO 9001 and EN 46001 certified.
6. The original document was written in English.
α 100 Users Manual
LOGIQ
2211157–100 Rev 0
Regulatory Req 1