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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(With Arrhythmia Detection Or Alarms)
510(k) Number K100046
Device Name M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000
Applicant
Guangdong Biolight Meditech Co., Ltd.
Suite 5d,#19, Ln. 999
Zhongshan Rd.(S-2)
Shanghai,  CN 200030
Applicant Contact Diana Hong
Correspondent
Guangdong Biolight Meditech Co., Ltd.
Suite 5d,#19, Ln. 999
Zhongshan Rd.(S-2)
Shanghai,  CN 200030
Correspondent Contact Diana Hong
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZQ   CCK   DQA   DRT   DSK  
DXN   FFL  
Date Received01/08/2010
Decision Date 04/08/2010
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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