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Medical equipment / Medical informatics / Blood tests / Healthcare / OneTouch Ultra / Medical device / Diabetes management / Food and Drug Administration / Blood glucose monitoring / Medicine / Health / Diabetes


Document Date: 2011-11-28 00:37:07

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City

Cary / /

Company

CHEK@ Advisor Insulin Guidance Software / rrI K103643 Trade / Ascot Technologies Inc. / Sirn Zuckernian M.D. / Program / Microsoft / /

Event

FDA Phase / Reorganization / /

Facility

Home Medical Station / Ascot Home Medical Station / /

/

IndustryTerm

computer 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 / /

MedicalCondition

disease / diabetes / suspected hypertension / /

OperatingSystem

Microsoft Windows / /

Organization

Sirn 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 / /

Person

Mary Ellen Randall / Mvarx' E'llen Randall / Mary Ellen / /

/

Position

Telehealtb Advisor / Advisor / President / Nurse / Physician / Summary GENERAL / Physician for review / /

Product

Home Medical Management System / HMS / Federal Food / RS232 / 2Q11 / /

ProvinceOrState

North Carolina / /

Technology

encryption / radiation / cellular telephone / wired communication protocols / communication protocols / Bluetooth / Telemedicine System / /

URL

www.f'da.gov/AboultFDA/CenitersOllfices/CDRII-l/CDI-IOfices/ucmiii / /

SocialTag