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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, physiological, patient (without arrhythmia detection or alarms)
510(k) Number K113833
Device Name VITAL SIGNS MONITOR
Applicant
GUANGDONG BIOLIGHT MEDITECH CO., LTD
P.O. BOX 237-023
SHANGHAI,  CN 200237
Applicant Contact Diana Hong
Correspondent
GUANGDONG BIOLIGHT MEDITECH CO., LTD
P.O. BOX 237-023
SHANGHAI,  CN 200237
Correspondent Contact Diana Hong
Regulation Number870.2300
Classification Product Code
MWI  
Date Received12/27/2011
Decision Date 05/01/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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