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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 K131762
Device Name HANDHELD MONITOR
Applicant
Guangdong Biolight Meditech Co., Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Applicant Contact Diana Hong
Correspondent
Guangdong Biolight Meditech Co., Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
DQA   DRT  
Date Received06/17/2013
Decision Date 06/06/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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