GE Brivo OEC 715 - Regulatory Requirements; European Representative; C-Arm Components; Performance Checks

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REGULATORY REQUIREMENTS
International Electrotechnical Commission (IEC), international standards organization, when
applicable.
This product conforms with the Medical Device Directive, Council Directive 93/42/EEC: June 14,
1993, as amended by 2007/47/EC following the provisions of Annex II, when it bears the
following CE Mark of Conformity.
European Representative:
GE Medical Systems S.C.S.
Quality Assurance Manager
283 rue de la Minière
78530 BUC France
Tel: +33 1 30 70 40 40