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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 K120193
Device Name ANY VIEW PATIENT MONITORS
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 Received01/23/2012
Decision Date 06/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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