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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 K090671
Device Name PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D
Applicant
Contec Medical System Co., Ltd.
Suite 8d, Zhongxin Zhongshan
Mansion, # 19 Lane 999
Zhong Shan, Shanghai,  CN 20030
Applicant Contact Diana Hong
Correspondent
Contec Medical System Co., Ltd.
Suite 8d, Zhongxin Zhongshan
Mansion, # 19 Lane 999
Zhong Shan, Shanghai,  CN 20030
Correspondent Contact Diana Hong
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/13/2009
Decision Date 06/11/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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