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Food law / Cardiology / Medical technology / Medical device / Premarket approval / Federal Food / Drug / and Cosmetic Act / Medical monitor / Heart rate / Cardiac event monitor / Medicine / Food and Drug Administration / Medical equipment


K13[removed]JUN[removed]Section[removed]k) Summry
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Document Date: 2014-07-18 16:15:47

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File Size: 160,67 KB

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City

Shanghai / /

Company

K131762 Trade / Guangdong Biolight Meditech Co. Ltd. / Sponsor Identification Guangdong Biolight Meditech Co. Ltd. / /

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Event

FDA Phase / /

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IndustryTerm

electrocardiographic monitoring equipment / Internet address httn//www.fda.sov/MedicalDevices/ResourcesforYou/Tndustrv/dcfault.htm / Internet address httn /

Organization

CORK-1 office of Device Evaluation / Food and Drug Administration / CDRH's office of Surveillance and BiometricsfDivision of Postmarket Surveillance / FDA / Cardiovascular Devices Office / Device Evaluation Center for Devices and Radiological Health for Br Enclosure / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / /

Person

Diana Hong / D. Zuckerman / Lee Eu / Jin Liang / /

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Position

Submission Correspondent / Director Tel / R&D Director / General / Director Division / /

Product

Motorola M800 Cellular Phone / Federal Food / /

Technology

radiation / html / /

URL

www.fda.uov/MedicalDevices/Sae / www.fda.sov/MedicalDevices/ResourcesforYou/Tndustrv/dcfault.htm / /

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