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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 K082641
Device Name FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL
Applicant
CONTEC MEDICAL SYSTEM CO., LTD.
SUITE 8D , ZHONGXIN ZHONGSHAN
MANSION, NO. 19, LANE 999,
ZHONG SHAN, SHANGHAI,  CN 20030
Applicant Contact Diana Hong
Correspondent
CONTEC MEDICAL SYSTEM CO., LTD.
SUITE 8D , ZHONGXIN ZHONGSHAN
MANSION, NO. 19, LANE 999,
ZHONG SHAN, SHANGHAI,  CN 20030
Correspondent Contact Diana Hong
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/11/2008
Decision Date 11/10/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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