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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K101694
Device Name HANDHELD PULSE OXIMETER MODEL M800
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 Number870.2700
Classification Product Code
DQA  
Date Received06/16/2010
Decision Date 09/08/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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