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![]() | Document Date: 2011-11-28 00:37:07Open Document File Size: 232,40 KBShare Result on FacebookCityCary / /CompanyCHEK@ Advisor Insulin Guidance Software / rrI K103643 Trade / Ascot Technologies Inc. / Sirn Zuckernian M.D. / Program / Microsoft / /EventFDA Phase / Reorganization / /FacilityHome Medical Station / Ascot Home Medical Station / / /IndustryTermcomputer media / healthcare judgment / wireless internet / wired communication protocols / real time monitoring / manufacturing practice requirements / lfyour device / communication protocols / marketed predicate devices / manufacturing practice / Internet address / Web Yes Yes / /MedicalConditiondisease / diabetes / suspected hypertension / /OperatingSystemMicrosoft Windows / /OrganizationSirn Zuckernian M.D. Director Office / Center for Devices and Radiological Health / office of Compliance / FDA / HUMAN SERVICES Public H-ealth Service / Device Evaluation Center for Devices / Division of Postinarket Surveillance / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / /PersonMary Ellen Randall / Mvarx' E'llen Randall / Mary Ellen / / /PositionTelehealtb Advisor / Advisor / President / Nurse / Physician / Summary GENERAL / Physician for review / /ProductHome Medical Management System / HMS / Federal Food / RS232 / 2Q11 / /ProvinceOrStateNorth Carolina / /Technologyencryption / radiation / cellular telephone / wired communication protocols / communication protocols / Bluetooth / Telemedicine System / /URLwww.f'da.gov/AboultFDA/CenitersOllfices/CDRII-l/CDI-IOfices/ucmiii / /SocialTag |