ExpressionMR400InstructionsforUseRegulatoryInformationC‐1
APPENDIX C
Regulatory Information
European Union
Declaration of Conformity
ToobtainacopyoftheDeclarationofConformitytotheEuropeanUnionMedicalDevice
Directive(93/42/EEC)andRadio & TelecommunicationsTerminalEquipmentDirective(1999/5/
EC),and/orRestrictiononHazardousSubstance(RoHS)Directive,contacttheRegulatoryAffairs
DepartmentatInvivo:
407‐275‐3220
‐or‐
1‐800‐331‐3220(toll‐free)
Internationally,
pleasecontactyourKeyMarketrepresentative.Gotowww.invivocorp.comfora
listing.Inaddition,copiesmaybeobtainedfromInCenter.
Authorized Representative
TheAuthorizedRepresentativefortheEuropeanUnion(asrequiredbytheMedicalDevice
Directive,93/42/E EC)isasfollows:
PhilipsMedizinSystemeBöblingenGmbH
Hewlett‐PackardStraße2
71034,Böblingen
Germany
Australia
TheAustraliaSponsor isasfollows:
PhilipsElectronicsAustraliaLtd
65EppingRoad,NorthRydeNSW2113
Australia