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Medical informatics / Anesthesia / Medical technology / Medical monitor / Medical device / Biomedical engineering / Cardiac event monitor / Pulse oximetry / Mindray Medical International Limited / Medicine / Cardiology / Medical equipment


KI23711I pg 1 of[removed]k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part[removed]Date: November[removed]
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Document Date: 2013-11-14 08:32:40

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File Size: 204,63 KB

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City

Washington Lane Parker / Shenzhen City / /

Company

Electronics Co. LTD. / Portable Patient Monitor Manufacturer Shenzhen Creative Industry Co. LTD. / Shenzhen Creative Industry Co. Ltd. / Kl2371l Trade / /

Currency

pence / /

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Event

FDA Phase / /

Facility

Hi-Tech Industrial Park / Drug Admniration New Hampshire Avenue Documnent control Center / /

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IndustryTerm

electrocardiographic monitoring equipment / respiratory gas monitors / Internet address http /

MedicalCondition

Delayed-Type Hypersensitivity / Irritation / /

Organization

Division of Postmarket Surveillance / office of Device Evaluation / FDA / Cardiovascular Devices Office / Device Evaluation Center for Devices and Radiological Health K123711I Indications for Use / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / CDRH's office of Surveillance / /

Person

Brain D. Zuckerman / Cardiac Monitor / Charles Mack / Wang Jia / /

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Position

Model / Correspondent / rt / General / Director Division / Principal Engineer / /

Product

2I1CFR / Drug / UP-7000 / /

ProvinceOrState

Guangdong Province / Arizona / /

Technology

radiation / /

URL

http /

SocialTag