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Cardiology / Food law / Medical informatics / Medical device / Medical monitor / Premarket approval / Federal Food / Drug / and Cosmetic Act / Title 21 of the Code of Federal Regulations / Cardiac event monitor / Medicine / Food and Drug Administration / Medical equipment


Document Date: 2012-03-26 00:31:45

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City

Shenzhen / /

Company

IBP / Edan Instruments Inc. / K113653 Trade / /

Country

China / /

Event

FDA Phase / Product Issues / /

/

IndustryTerm

healthcare facility / Internet address htp/wwfagvMdcleie/eorefro/nutydfuthm / predicate device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / /

MedicalCondition

Arrhythmia / MS / /

MedicalTreatment

ORT / /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Device Evaluation Center for Devices and Radiological Health Enclosure Patient Monitor Traditional 510OK Submission Section / Cardiovascular Devices Office / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / CDRH's office of Surveillance / Division of Cardiovascular Devices / /

Person

Silver Spring / Randy Jiang / /

/

Position

physician / Director Division / Certification Engineer / /

Product

Intended / Federal Food / electrodes / /

ProvinceOrState

Maryland / /

Technology

radiation / /

URL

http /

SocialTag