GE LOGIQ 500 Advanced Reference Manual

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GE LOGIQ 500 Advanced Reference Manual Manual pdf 5 page image

Regulatory RequirementsLOGIQ 500 Advanced Reference Manual2276614–100 Rev. 0Regulatory Req 1Regulatory RequirementsThis product complies with the regulatory requirements of thefollowing: Council Directive 93/42/EEC concerning medical devices:the label affixed to the product testifies complianceto the Directive.The location of the CE marking is shown on 2–24 of thismanual.European registered place of business:GE Medical Systems EuropeQuality Assurance ManagerBP 34F 78533 BUC CEDEX FranceTel: +33 (0)1 30 70 40 40 Medical Device Good Manufacturing Practice Manualissued by the FDA (Food and Drug Administration,Department of Health, USA). Underwriters’ Laboratories, Inc. (UL), an independenttesting laboratory. Canadian Standards Association (CSA). International Electrotechnical Commission (IEC),international standards organizations, when applicable.Caution: United States law restricts this device to sale or use byor on the order of a physician.General Electric Medical Systems is ISO 9001 andEN 46001 certified. The original document was written in English. For USAOnly